A Phase II, Open Label, Multi-center Study of 89Zr-DF-Crefmirlimab for CD8 Positron Emission Tomography in Patients With Locally Advanced or Metastatic Solid Tumours

This is a multi-center, single-arm trial designed to evaluate the safety and imaging characteristics of 89Zr-Df-crefmirlimab in patients with locally advanced or metastatic solid tumours prior to and during PD-1 antibody therapy.

开始日期2024-12-01

申办/合作机构

University Medical Center Groningen

NCT06311578

/ Recruiting临床1期

Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors

The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.

开始日期2024-04-10

申办/合作机构

Johnson & Johnson Enterprise Innovation, Inc.

NCT06116786

/ Recruiting临床1期

A Phase 1 Study of JNJ-86974680, an A2a Receptor Antagonist, Administered as Monotherapy and in Combination With Cetrelimab and Radiotherapy for Advanced Non-small Cell Lung Cancer

The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for further research in combination with cetrelimab and radiation therapy.

开始日期2023-11-27

申办/合作机构

Johnson & Johnson

100 项与 Cetrelimab 相关的临床结果

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100 项与 Cetrelimab 相关的转化医学

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100 项与 Cetrelimab 相关的专利（医药）

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项与 Cetrelimab 相关的文献（医药）

2025-01-01·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Development of TAR-200: A novel targeted releasing system designed to provide sustained delivery of gemcitabine for patients with bladder cancer

Review

作者: Williams, Stephen B ; Catto, James W F ; Chang, Sam S ; Xylinas, Evanguelos ; Galsky, Matthew D ; Sweiti, Hussein ; Shore, Neal D ; Cutie, Christopher ; Guerrero-Ramos, Félix ; Miyake, Makito ; Jacob, Joseph M ; Necchi, Andrea ; Daneshmand, Siamak ; van der Heijden, Michiel S ; Kamat, Ashish M ; Meeks, Joshua J ; Daniel, Karen ; Powles, Thomas ; Simone, Giuseppe ; Psutka, Sarah P

Treatment options for recurrent high-risk non-muscle-invasive bladder cancer (HR NMIBC) and muscle-invasive bladder cancer (MIBC) are limited, highlighting a need for clinically effective, accessible, and better-tolerated alternatives. In this review we examine the clinical development program of TAR-200, a novel targeted releasing system designed to provide sustained intravesical delivery of gemcitabine to address the needs of patients with NMIBC and of those with MIBC. We describe the concept and design of TAR-200 and the clinical development of this gemcitabine intravesical system in the SunRISe portfolio of studies. This includes 3 phase I studies evaluating the safety and initial tumor activity of TAR-200 and 5 phase II/III studies assessing the efficacy and safety of TAR-200, with or without systemic cetrelimab, as a treatment option for patients with HR NMIBC (bacillus Calmette-Guérin naive [papillary and carcinoma in situ] and MIBC (neoadjuvant and patients ineligible for or refusing radical cystectomy). Pharmacokinetics demonstrate intravesical gemcitabine delivery via TAR-200 over a prolonged period without detectable plasma levels. Phase I studies showed that TAR-200 is well tolerated, with preliminary antitumor activity in intermediate-risk NMIBC and MIBC. Preliminary data from the phase IIb SunRISe-1 study demonstrate that TAR-200 monotherapy is safe and effective in patients with bacillus Calmette-Guérin-unresponsive high-risk NMIBC. TAR-200 represents an innovative approach to the local treatment of bladder cancer.

2024-08-01·INVESTIGATIONAL NEW DRUGS

A phase 1/1b, open-label, dose-escalation study of PD-1 inhibitor, cetrelimab alone and in combination with FGFR inhibitor, erdafitinib in Japanese patients with advanced solid tumors

Article

作者: Koyama, Takafumi ; Doi, Toshihiko ; Kondo, Shunsuke ; Suzuki, Noriko ; Mukai, Mayumi ; Harano, Kenichi ; Hagiwara, Akiko ; Yamamoto, Noboru ; Kuboki, Yasutoshi ; Fujikawa, Ei ; Toyoizumi, Kiichiro

Abstract:

Immune checkpoint inhibitors are the leading approaches in tumor immunotherapy. The aim of the study was to establish recommended phase 2 doses (RP2Ds) of intravenous cetrelimab, a checkpoint inhibitor, alone and with oral erdafitinib in Japanese patients with advanced solid tumors. This open-label, non-randomized, dose-escalation phase 1/1b study enrolled adults with advanced solid tumors who were ineligible for standard therapy. Study was conducted in two parts: phase 1a assessed cetrelimab at three dosing levels (80 mg every 2 weeks [Q2W], 240 mg Q2W, and 480 mg Q4W); phase 1b assessed cetrelimab+erdafitinib at two dosing levels (240 mg Q2W + 6 mg once daily [QD] and 240 mg Q2W + 8 mg QD). Primary endpoint was frequency and severity of dose-limiting toxicities (DLTs) of cetrelimab ± erdafitinib. In total 22 patients (phase 1a, n = 9; phase 1b, n = 13) were enrolled. Median duration of follow-up was 8.64 months in phase 1a and 2.33 months in phase 1b. In phase 1a, DLTs weren’t reported while in phase 1b, 1 patient who received 240 mg cetrelimab + 6 mg erdafitinib reported Stevens-Johnson syndrome (grade 3, immune-related). Overall, 88.9% patients in phase 1a (grade ≥ 3: 44.4%) and 100.0% in phase 1b (grade ≥ 3: 53.8%) experienced ≥ 1 treatment-related adverse events (TEAEs); 33.3% in phase 1a and 38.5% in phase 1b reported serious TEAEs, of which 11.1% patients in phase 1a and 15.4% in phase 1b had TEAEs which led to treatment discontinuation. Cetrelimab alone and in combination with erdafitinib showed manageable safety in Japanese patients with advanced solid tumors. RP2Ds were determined as 480 mg cetrelimab Q4W for monotherapy, and cetrelimab 240 mg Q2W + erdafitinib 8 mg QD for combination therapy.

2023-08-01·Aktuelle Urologie

[First-line maintenance therapy of adult patients with BCG-naïve high-risk non-muscle-invasive bladder cancer - A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants with BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) - SunRISe-3 - AB 85/23 of AUO].

Article

项与 Cetrelimab 相关的新闻（医药）

2025-02-21

·SYNAPSE

Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer

Study results of novel drug-eluting technology highlight potential durability of TAR-200 in patient population with high unmet need CHICAGO, April 30, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the first results from the open-label Phase 2 SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy (a novel investigational intravesical drug delivery system) and cetrelimab monotherapy (an investigational anti-PD-1 monoclonal antibody administered intravenously) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for, or decline, radical cystectomy. The study demonstrated that 72.7 percent of patients treated with TAR-200 alone (95 percent confidence interval [CI] 49.8-89.3) and 38.1 percent of patients treated with cetrelimab alone (CI 18.1-61.6) achieved the primary endpoint of a complete response (CR). These data were featured today in a Late Breaker Podium Presentation Session (Abstract #LBA02-03) at the American Urological Association Annual Meeting (AUA). “We continue to see significant unmet need among high-risk patients with non-muscle-invasive bladder cancer, who often experience negative outcomes and poor quality of life with existing standard of care treatments, such as radical cystectomy,” said Siamak Daneshmand*, M.D., Professor of Urology, Director of Urologic Oncology at the Norris Comprehensive Cancer Center, Keck School of Medicine of University of Southern California and SunRISe-1 study principal investigator. “As a clinician, my ultimate treatment goal is to achieve deep and durable responses in these patients. It is encouraging to see an improvement among those treated with TAR-200 alone, as well as cetrelimab alone, and we look forward to reporting on results from the study cohort that is evaluating these two treatments in combination in the future.” HR-NMIBC includes lesions confined to the bladder mucosa and has a higher likelihood of local recurrence and distant progression to other parts of the body. HR-NMIBC is typically treated with BCG – a type of intravesical immunotherapy – as the standard of care. BCG involves injecting a weakened form of tuberculosis bacteria into the bladder, stimulating the immune system to attack the cancer cells; however, approximately one-third of HR-NMIBC patients will not respond to the treatment. For BCG-unresponsive patients, there is an anti-PD-1 monoclonal antibody as an alternate, approved treatment option. NMIBC represents some 70 percent of newly diagnosed bladder cancer cases, of which 10 percent are carcinoma in situ (CIS), early cancer cells confined within the innermost layer of the bladder lining; 50 percent of all cases of CIS will progress to muscle-invasive bladder cancer (MIBC) within 5 years if left untreated. TAR-200 is a novel investigational intravesical drug delivery system designed to provide sustained local release of gemcitabine into the bladder urine. Cetrelimab is an investigational anti-PD-1 monoclonal antibody administered intravenously. The SunRISe-1 study evaluated patients with histologically confirmed CIS, with or without concomitant high-grade Ta (CIS) or T1 (CIS cases with higher risk of progressing to MIBC) papillary disease, a type of NMIBC. Patients were randomized to one of three cohorts: treatment with TAR-200 in combination with cetrelimab (Cohort 1 [C1]), TAR-200 alone (Cohort 2 [C2]) or cetrelimab alone (Cohort 3 [C3]). C2 and C3 results were reported at AUA with C1 results to be reported at a future date. The primary endpoint of CR at any time was determined by cystoscopy, central cytology, and central pathology (Weeks 24 and 48). Secondary endpoints included duration of response (DOR), overall survival (OS), pharmacokinetics, quality of life, safety, and tolerability. Preliminary results of the SunRISe-1 study included 23 evaluable patients in C2 and 24 evaluable patients in C3. After median follow-up of 10.6 months, 15 of 16 responses in C2 are still ongoing; median DOR was not reached. Additionally, six of the patients in C2 maintained their response beyond 12 months and none of the complete responders had documented recurrence or progression. The initial findings from SunRISe-1 showed low rates of grade three or higher adverse events (AEs) and a limited number of treatment discontinuations due to adverse events were observed with TAR-200. The most common AEs were pollakiuria (34.8 percent), micturition urgency (34.8 percent), dysuria (26.1 percent), and noninfective cystitis (21.7 percent) in C2; pruritus (20.8 percent) and diarrhea (20.8 percent) occurred in patients in C3. Seven patients in C2 (30.4 percent) and two patients in C3 (8.3 percent) had AEs that were grade three or higher. “Our ambition is to improve the lives of patients living with non-muscle and muscle-invasive bladder cancers and redefine the treatment of this disease in the future,” said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Janssen Research & Development, LLC. “With the innovative TAR-200 intravesical drug delivery system, we are committed to advancing bladder cancer treatment across the spectrum of this disease, and we look forward to providing further updates from our robust SunRISe clinical program.” Bladder cancer is the sixth most common cancer in the United States, with more than 80,000 patients diagnosed annually, and is the tenth most common cancer worldwide, with more than 600,000 patients diagnosed each year.Bladder cancer occurs when cells in the bladder tissue grow uncontrollably, often forming a tumor that can then spread to other parts of the body if left untreated. Non-muscle-invasive bladder cancers are limited to the urothelium, the innermost layer of the bladder, and may be less aggressive than muscle-invasive bladder cancer, a type of cancer that arises from the muscular layer of the bladder or has grown beyond the urothelium and is more likely to spread to other parts of the body. About SunRISe-1 SunRISe-1 (NCT04640623) is a Phase 2 randomized, parallel-assignment, open-label clinical study evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC CIS patients who are ineligible for, or decline, radical cystectomy. Participants are randomized to one of three cohorts: treatment with TAR-200 in combination with cetrelimab (C1), TAR-200 alone (C2), or cetrelimab alone (C3). The primary endpoint is CR rate at any time point. Secondary endpoints include DOR, OS, pharmacokinetics, quality of life, safety, and tolerability. About TAR-200 TAR-200 is an investigational drug delivery system, enabling controlled release of gemcitabine into the bladder, increasing dwell time and local drug exposure. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with muscle-invasive bladder cancer in SunRISe-2 and SunRISe-4 and NMIBC in SunRISe-1 and SunRISe-3. About Cetrelimab Administered intravenously, cetrelimab is an investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied to treat bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination treatment. Cetrelimab is also being evaluated in multiple other combination regimens across the Janssen Oncology portfolio. About High-risk Non-Muscle-Invasive Bladder Cancer High-risk non-muscle-invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC. HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, and CIS. Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression. Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy. The high rates of recurrence and progression can pose significant morbidity and distress for these patients. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension. The content above comes from the network. if any infringement, please contact us to modify.

2025-01-31

·ioncology

年度盘点丨优患所忧，及患所急！魏强教授回顾2024年膀胱癌治疗进展

- 年度盘点 - 2024年膀胱癌治疗进展魏强教授编者按：膀胱癌是常见的泌尿系统恶性肿瘤之一，严重威胁着国人生命健康。对于局限期患者而言，长期反复的膀胱腔内治疗或检查操作，使患者需要频繁住院或门诊随访；可手术患者也有长期背尿袋的“难言之隐”；而不可手术的晚期患者通过传统化疗的治疗获益较为有限。因此，无论是生存还是生活质量，膀胱癌患者都存在巨大的未被满足的治疗需求，这也是泌尿外科医生、肿瘤科医生为之探索创新的动力。值此辞旧迎新之际，《肿瘤瞭望》特邀四川大学华西医院魏强教授回顾2024年膀胱的治疗进展。这些新的研究突破，有望为膀胱癌患者带来延长生存、改善生活质量的“双赢”治疗策略。 01 NMIBC：局部和系统治疗“并蒂花开” 非肌层浸润性膀胱癌（NMIBC）是最常见的膀胱癌类型，约占初诊患者的四分之三。经尿道膀胱肿瘤切除（TURBt）是NMIBC的首选治疗[1]，但仍有约一半的患者可在1年内复发[2]。目前，国内外指南共识根据NMIBC复发进展风险和预后的不同，将其分为低危、中危、高危和极高危。针对中高危及以上患者，通常使用卡介苗（BCG）膀胱灌注免疫治疗，但仍有部分患者对BCG无反应，或无法耐药BCG相关不良反应（如膀胱炎、血尿、感染、发热等），且部分国家和地区存在BCG供应不足的情况。近年来，有诸多研究采用新的局部或系统治疗策略，以应对BCG灌注无反应问题，以及降低复发和进展风险。这些治疗策略涵盖了化疗、免疫治疗以及新型药物的膀胱腔内治疗或系统治疗。化疗免疫治疗其他新型药物多种药物联合灌注灌注剂量与频率优化 ADC类腔内灌注热灌注 BCG与化疗联合灌注 FGFR3 TKI靶向药物增加灌注频率与时长（Chemoablation） BCG与化疗序贯灌注病毒样药物偶联物（virus-like drug conjugates，VDC）持续释放（TAR200） BCG与ICI序贯治疗溶瘤腺病毒CG0070 逆温凝胶化疗灌注 BCG与ICI联合治疗 IL-15超激动剂 _ _ 免疫增强剂TARA-002 TAR-200腔内治疗 TAR-200是一种半渗透性的硅胶管状结构，可以在膀胱内持续数周连续释放化疗药物（吉西他滨）的新型给药系统。SunRISe系列研究在不同治疗场景探讨了基于TAR-200的治疗模式，如SunRISe-1和SunRISe-5是针对BCG无反应的高危NMIBC，采用TAR-200联合Cetrelimab（PD-1单抗）或者单独TAR-200、Cetrelimab治疗的II期和III期研究；SunRISe-2和SunRISe-4则是针对肌层浸润性膀胱癌（MIBC）患者，分别采用TAR-200联合Cetrelimab对比GC＋放疗的III期研究，以及采用TAR-200联合Cetrelimab新辅助治疗的II期研究；SunRISe-3则是针对初治的高危NMIBC患者，采用TAR-200或BCG灌注治疗的III期研究。 2024年ESMO大会报道了SunRISe-1研究[3]结果，针对BCG无反应的高危NMIBC的患者，队列1（TAR-200＋Cetrelimab）、队列2（TAR-200）、队列3（Cetrelimab）确认的总体CR率分别为67.9%、83.5%和46.4%；1年CR率则分别为56.7%、57.4%和22.8%。单独使用TAR-200（6%）和cetrelimab（7%）时，因治疗相关不良事件（TRAE）导致的停药率较低，而联合使用时停药率较高（TAR-200 26%或cetrelimab 23%）。未发生治疗相关死亡。这项研究初步展示了TAR-200腔内治疗具有较高的CR率和可控的安全性。 ADC系统治疗维迪西妥单抗（RC48）、维恩妥尤单抗（EV）等靶向于HER2、Nectin-4的新型ADC，已经在mUC领域一线免疫联合治疗取得突破性进展。这种“靶向化疗”药物相较于传统化疗具有增效减毒的特征。近年来，新型ADC开始拓展至局限期膀胱癌的治疗，包括针对NMIBC的系统治疗或膀胱灌注治疗。例如2023年ASCO大会报道的EV-104研究[4]，是一项正在进行的开放标签、多中心、剂量递增I期试验，该研究显示静脉注射EV用于BCG无应答的高危NMIBC患者的耐受性良好。125mg剂量时观察到了初步抗肿瘤活性，4例患者中有3例达到了CR。2024年ASCO大会也报道了RC48用于高危NMIBC患者的初步疗效数据[5]，在入组的27例患者中，有10例患者接受维迪西妥单抗、17例患者接受BCG。研究结果显示HER2过表达显著影响膀胱癌的肿瘤免疫响应；而且RC48相比BCG具有更高的1年RFS率（100% vs 58.8%）。2024年AUA大会公布的TRUCE04研究[6]，在24例肿瘤无法完全切除或无法耐受手术并且HER2中高表达（IHC 2+或3+）的NMIBC患者中，有8例患者接受了RC48单药治疗，16例患者接受了RC48联合替雷利珠单抗治疗，结果显示有16例患者达到完全缓解（CR），8例患者达到疾病稳定（SD）。 ICI灌注治疗如前所述，SunRISe系列研究中探讨了TAR-200腔内治疗单独或联合免疫检查点抑制剂（ICI）的系统治疗；当前的大多数研究也主要将ICI作为系统治疗。从理论上来看，ICI阻断PD-1/PD-L1的免疫逃逸机制，与BCG同样具有免疫激活效果，但二者是否具有协同增效作用？一项由希腊生殖和泌尿癌症协作组开展的开放标签、单臂、多中心、Ⅱ期临床试验[7]，两个阶段共入组30例高危NMIBC患者，接受度伐利尤单抗的膀胱灌注治疗。结果发现，在灌注后1年，19例可评估患者中有7例仍未出现高级别复发（1年HG-RFR：38.5%）。研究治疗结束后1、3和6个月的HG-RFR分别为70%、55%和38.5%。除局部刺激外，没有发现严重不良事件。该研究初步展现了ICI膀胱腔内治疗的抗肿瘤活性，未来仍有不少值得进一步探讨的问题，例如ICI与BCG应该进行序贯的还是联合的腔内治疗？如果序贯治疗应该先试用ICI还是BCG？ 02 MIBC：围手术期治疗“百花齐放” MIBC的标准治疗是根治性膀胱切除术，但有不少患者难以接受尿流改道带来的生活质量损害，而且部分患者仍面临术后疾病复发或进展风险。因此，MIBC围术期治疗焦点主要通过术前和/或术后治疗，达到肿瘤降期、延长保膀胱生存以及降低术后复发风险的目的。 ICI辅助和新辅助治疗 CheckMate-274研究开启了MIBC辅助免疫治疗时代，既往发表于NEJM的结果[8]显示，针对高危MIBC（未接受新辅助铂类治疗或不适合辅助铂类治疗的pT3、pT4a或pN+患者；接受过新辅助铂类治疗的ypT2至ypT4a或ypN+患者），纳武利尤单抗辅助治疗可显著改善DFS（20.8 vs 10.8个月，HR 0.70；98.22%CI：0.55~0.90；P<0.001），其总生存（OS）结果令人十分期待。2024年EAU大会上，首次报道了该研究的OS数据[9]，纳武利尤单抗组和安慰剂组的中位OS分别为69.5个月和50.1个月，死亡风险降低24%（HR 0.76，95%CI：0.61-0.96）；而PD-L1≥1%的人群中，纳武利尤单抗组的死亡风险降低44%（NR vs NR；HR 0.56，95%CI：0.36-0.86）。 AMBASSADOR研究是另一个ICI辅助治疗MIBC的III期研究。该研究入组患者为新辅助化疗后≥pT2和/或pN+/切缘阳性，以及不适合或拒绝新辅助化疗的≥pT3和/或pN+/切缘阳性患者，术后接受帕博利珠单抗或安慰剂辅助治疗1年。2024年ASCO-GU大会报道达到了研究的主要终点之一DFS：帕博利珠单抗组和对照组的中位DFS分别为29.0个月和14.0个月（HR 0.69，95%CI 0.54～0.87，P=0.001）。但另一个主要终点OS尚无显著差异（50.9 vs 55.8个月，HR 0.98，95%CI：0.76～1.26；P=0.883）[10]。 NIAGARA研究则是将免疫治疗贯穿于术前新辅助和术后辅助治疗，针对入组的顺铂耐受且计划进行根治性膀胱切除的MIBC（cT2-T4aN0/1M0）患者，试验组接受4个周期的术前度伐利尤单抗联合GC新辅助治疗，术后接受8个周期的度伐利尤单抗辅助治疗。对照组则仅接受新辅助化疗，研究的主要终点是EFS和pCR。2024年ESMO报道且同步发表于NEJM的结果显示，试验组和观察组患者的中位DFS分别为29.6个月和14.2个月（HR 0.73；95% CI，0.59~0.90；P=0.003），pCR率分别为37.3%和27.4%。但次要终点OS，目前尚未观察到显著性差异（HR，0.98；95%CI：0.17~1.26）[11]。 ADC新辅助治疗多队列、II期SURE-01研究，入组了21名不符合或拒绝接受顺铂新辅助化疗的cT2-4N0M0 MIBC患者，给予4个周期的TROP2 ADC戈沙妥珠单抗（SG）新辅助治疗，2024年ASCO报道的结果显示[12]，在11例接受根治性手术患者中，有4例（36.4%）达到了pCR。同样为多队列的II期EV-103研究，报道了队列H的结果[13]，该队列入组了顺铂不合格的MIBC（T2-T4aN0M0）患者，在术前接受3个周期的EV新辅助治疗，在可评估的患者中，pCR率为36.4%，病理降期（pDS）率为50.0%；2年EFS率为62.0%。II期RC48-C017研究[14]入组了未接受过治疗的MIBC（cT2-T4aN0-1M0）患者，术前接受6个周期的RC48联合特瑞普利单抗新辅助治疗，pCR率为61.3%（19/31）。这些研究都初步展现了ADC在MIBC新辅助治疗中的抗肿瘤活性，有较高的肿瘤降期作用。 TAR-200新辅助治疗 2024年ESMO大会报道了TAR-200用于MIBC新辅助治疗的SUNRISE-4研究[15]，入组患者术前接受4个周期的TAR-200膀胱内治疗联合Cetrelimab静脉注射治疗，或者单独Cetrelimab静脉注射治疗，然后接受根治性手术并继续术后随访。研究结果显示，TAR-200+Cetrelimab组和Cetrelimab组确认的病理完全缓解（pCR，ypT0N0）率分别为42%和23%，总体病理缓解（pOR；≤ypT1N0）率分别为60%和36%。TAR-200+cetrelimab和cetrelimab分别有72%和44%患者出现治疗相关不良事件（TRAE），其中大多为1-2级。 03 mUC：“免疫plus”涌现更多组合在转移性尿路上皮癌（mUC）领域，既往IMvigor130与KEYNOTE-361的阴性结果，为ICI联合化疗的应用蒙上一层“阴影”，但此后仍有更多免疫联合治疗模式的探索，包括联合化疗、ADC治疗以及FGFR靶向治疗等。 ICI联合化疗 ADC：后线单药，前线顺铂不耐联合免疫 FGFR：特定突变患者 IMvigor130与Keynote361均为阴性结果 EV 103 cohort A：mUC一线顺铂不耐受 EV + Pembro NORSE：mUC一线顺铂不耐受，Erda + Cetrelimab vs. Erda Checkmate 901：NIVO+GC获得阳性结果 EV 103 cohort K：mUC多重后线顺铂不耐受 THOR：mUC多重后线， Erda vs. 后线化疗 _ TROPHY-U-01：mUC多重后线，UGT1A1酶多重活性 SG单药 _ _ EV-302: mUC一线 EV+Pembro vs. Chemo _ _ RC48 C014: mUC 前/后线 RC48+PD1 _ EV-302研究：ADC＋ICI EV-302研究则是全球首个证实ADC联合免疫治疗作为mUC一线治疗并获阳性结果的III期临床试验。既往发表于NEJM的结果[18]显示，与单独化疗相比，EV＋帕博利珠单抗组的mPFS（12.5 vs. 6.3个月；HR 0.45，95%CI：0.38~0.54；P<0.001）和mOS（31.5 vs. 16.1个月；0.47，95%CI：0.38~0.58；P<0.001）均几乎延长了一倍。2024年ASCO大会进一步报道了该研究的患者报告结局（PRO）[19]。结果发现，EV＋帕博利珠单抗联合治疗并不会降低患者的生活质量和身体机能，这也进一步表明了联合治疗对于mUC的临床应用价值。而2024年ESMO Asia报道在泛亚洲亚组中，EV＋帕博利珠单抗组的PFS事件风险更是降低了70%（NE vs. 6.3个月，HR 0.30，95%CI：0.19~0.48），亚洲患者在OS方面也同样显示出更大幅度的获益趋势，死亡风险降低66%（HR 0.34，95%CI：0.18~0.65） 04 总结随着诊疗研究的深入，膀胱癌的治疗已经呈现多元化、个体化的综合治疗发展趋势，涵盖了从NMIBC到MIBC、mUC各个疾病阶段的局部治疗和系统治疗，均涌现了许多新型的治疗手段或药物。在NMIBC领域，最令人瞩目的莫过于TAR200等创新的腔内治疗手段有望促使更多的局部治疗变革；而MIBC围术期治疗无论是新辅助、辅助治疗还是保膀胱治疗，在ADC、ICI等新型药物的加持下，都产生了新的疗效飞跃；而在mUC领域，不同联合治疗模式为晚期患者带来了更多延长生存的希望，尤其是免疫联合化疗或ADC涌现了即将或已经改变临床实践的循证医学证据。参考文献上下滑动查看更多内容 [1]中国肿瘤医院泌尿肿瘤协作组. 膀胱癌早诊早治专家共识（2024年版）［J］. 中国癌症杂志, 2024, 34 (6): 607-618. [2]Sylvester, Richard J., et al. 'Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials.' European urology 49.3 (2006): 466-477. [3]Michiel S. Van der Heijden, et al. TAR-200 +/- cetrelimab (CET) and CET alone in patients (pts) with bacillus Calmette-Guérin-unresponsive (BCG UR) high-risk non-muscle-invasive bladder cancer (HR NMIBC): Updated results from SunRISe-1 (SR-1). ESMO2024. LBA 85. [4]Ashish M. Kamat,et al.A first-in-human trial of intravesical enfortumab vedotin (EV), an antibody-drug conjugate (ADC), in patients with non-muscle invasive bladder cancer (NMIBC): Interim results of a phase 1 study (EV-104).J Clin Oncol 41, 2023 (suppl 16; abstr 4596) [5]Haoyang Liu, et al. The tumor immune profile of bladder cancer (BC) with HER2 over-expression and the investigation into RC48-ADC versus BCG in high-risk non-muscle invasive BC with HER2 over-expression.2024 ASCO. Abstract e16614. [6]Huhailong, et al.TRUCE04: A Phase ll Clinical Trial of RC48 for High-Risk Non-Muscle-InvasiveBladder Cancer(HR-NMIBC)(NCTO5495724). 2024 AUA. Abstract 0955. [7]Fragkoulis C. et al. Intravesical administration of Durvalumab to patients with high risk non muscle invasive bladder cancer who experience BCG failure. Final results from a phase II study by the Hellenic GU Cancer Group. EAU 2024. A0741 [8]Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma [published correction appears in N Engl J Med. 2021 Aug 26;385(9):864. doi: 10.1056/NEJMx210012]. N Engl J Med. 2021;384(22):2102-2114. doi:10.1056/NEJMoa2034442 [9]M. Galsky, et al. Extended follow-up from CheckMate 274 including the first report of overall survival outcomes. EAU 2024. [10]Andrea B. Apolo, et al.AMBASSADOR Alliance A031501: Phase III randomized adjuvant study of pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma (MIUC) vs observation.J Clin Oncol 42, 2024 (suppl 4; abstr LBA531) [11]Thomas B. Powles, et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024. LBA5. [12]Antonio Cigliola, Marco Moschini, Valentina Tateo, et al. Perioperative sacituzumab govitecan (SG) alone or in combination with pembrolizumab (Pembro) for patients with muscle-invasive urothelial bladder cancer (MIBC): SURE-01/02 interim results. ASCO 2024. LBA4517. [13]O'Donnell, P. H., et al. Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)—2-year event-free survival and safety data for Cohort H. ASCO 2024. 4564-4564 [14]Xinan Sheng, et al. Preliminary efficacy and safety results from RC48-C017: A phase II study of neoadjuvant treatment with disitamab vedotin plus toripalimab in patients with muscle invasive bladder cancer (MIBC) with HER2 expression. ASCO 2024 4568 [15]Andrea Necchi, et al. TAR-200 plus cetrelimab (CET) or CET alone as neoadjuvant therapy in patients (pts) with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant cisplatin-based chemotherapy (NAC): Interim analysis of SunRISe-4 (SR-4). ESMO 2024. LBA84. [16]van der Heijden MS, Sonpavde G, Powles T, et al. Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma. N Engl J Med. 2023;389(19):1778-1789. doi:10.1056/NEJMoa2309863 [17]Matt D. Galsky, et al. Characterization of complete responders to nivolumab + gemcitabine-cisplatin vs gemcitabine-cisplatin alone and patients with lymph node–only metastatic urothelial carcinoma from the CheckMate 901 trial. ASCO 2024,abstract 4509 [18]Powles T, Valderrama BP, Gupta S, et al. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024;390(10):875-888. doi:10.1056/NEJMoa2312117 [19]Michiel Simon Van Der Heijden, , et al. Enfortumab vedotin (EV) in combination with pembrolizumab (P) versus chemotherapy in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC): Subgroup analyses results from EV-302, a phase 3 global study. ASCO 2024. LBA530 魏强教授四川大学华西医院四川大学华西医院泌尿系统疾病中心主任、泌尿外科学科主任、教授、博导中华医学会泌尿外科学分会副主任委员中国医师协会泌尿外科医师分会副会长中国临床肿瘤学会（CSCO）前列腺癌、肾癌专委会副主任委员中国抗癌协会男生殖肿瘤专委会副主任委员四川省肾病及泌尿系统疾病临床研究中心主任四川省医师协会外科机器人医师分会会长四川省抗癌协会泌尿男生殖肿瘤专委会主任委员成都市医学会泌尿外科分会主任委员获CUA“金膀胱镜奖”吴阶平泌尿外科医学奖及全球华人泌尿外科终身成就奖（来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

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强生猛攻膀胱癌

近期，强生宣布已向FDA提交TAR-200的新药申请，用于对卡介苗治疗无反应的高风险非肌层浸润性膀胱癌伴原位癌（可伴或不伴乳头状肿瘤）患者。此前，强生在膀胱癌领域还有一个更大的突破，其泛FGFR抑制剂厄达替尼（Erdafitinib）正式获NMPA批准，用于治疗携带易感型FGFR3基因变异，且既往接受至少一线含抗PD-1或抗PD-L1期间或之后出现疾病进展的手术不可切除的局部晚期或转移性尿路上皮癌（UC）成人患者。长期深耕男性泌尿肿瘤的强生，在前列腺癌领域凭借阿比特龙和阿帕他胺两款重磅产品牢牢占据了前列腺癌市场领先地位。如今，又强势入局膀胱癌领域，有意巩固其泌尿肿瘤霸主地位的野心昭然。 1 新颖的药物形式 TAR-200最初由Taris Biomedical公司开发，强生于2019年底收购了这家公司。该公司致力于开发用于治疗包括膀胱癌在内的泌尿系统疾病的新型药物递送技术，自主研发了TARIS系统。TARIS系统是一种基于硅酮的药物输送装置，可使用微创方法植入体内并从膀胱中取出。这个系统可以将药物直接释放到膀胱肿瘤，评估针对膀胱癌和其他类型癌症患者的新型局部治疗方法。膀胱癌基因容易激活突变，异常基因型的长期积累会导致恶性表型的出现。TARIS系统以一种量身定制的方法提供联合治疗，可以治疗多种膀胱癌类型。 TAR-200是第一个也是唯一个针对膀胱癌的膀胱内药物释放系统，可以通过一根5厘米长的硅胶管，利用其渗透性将化疗药吉西他滨持续、可控地释放到膀胱中，与传统的2小时膀胱灌注时间相比，它可以实现连续几周到几个月向膀胱输送药物。吉西他滨是膀胱癌化疗的首选药物。图片来源：EtudeImpromptu ImpromptuThoughts 作为一种新的膀胱内递送系统，TAR-200能够使肿瘤持续暴露于药物中，并且对比其他化疗或其他药物，TAR-200使肿瘤暴露于药物的总时间更长。同时，TAR-200通过局部给药产生的疗效强大，与标准吉西他滨膀胱内灌注相比，TAR-200的给药剂量明显较低，还不易发生常规化疗导致的患者全身性药物暴露，能够大幅降低毒副作用。此外，比较方便的是，TAR-200易于安装，安装过程仅需3～5分钟，无需麻醉即可完成。这一创新膀胱内药物释放系统的提交，得到了来自2b期SunRISe-1注册研究的数据支持，已在2024 ESMO年会上作为临时口头报告呈现。TAR-200单药治疗显示出83.5%的完全缓解率（CR），并且CR具有高度耐久性，无需重新诱导治疗——在中位随访9个月时，82%的反应者维持了反应。这个数据目前看起来是所有HR-NMIBC在研产品里面单药CR率最高的。 2 竞争进入白热化膀胱癌作为全球高发的恶性肿瘤之一，分为非肌层浸润性膀胱癌（NMIBC，占70%）和肌层浸润性膀胱癌（MIBC，占30%）两大类。非肌层浸润性膀胱癌包括膀胱的原位癌、非浸润性乳头状癌，以及侵犯上皮下结缔的膀胱癌，肌层浸润性膀胱癌是指侵犯浅肌层以上的膀胱癌。 NMIBC是早期阶段膀胱癌，肿瘤的浸润深度尚未超过尿路壁的浅表层。同时，NMIBC也是最常见的膀胱癌类型，约占膀胱肿瘤新发病例的75%。根据弗若斯特沙利文分析，中国NMIBC市场规模在2015-2019年的复合年增长率为14.4%，中国NMIBC市场将继续保持增长，预计于2024年达到26亿元，2030年预计达到88亿元。 NMIBC的标准治疗方式是经尿道膀胱肿瘤切除术（TURBT），微创手术之后临床指南推荐化疗灌注和卡介苗（BCG）膀胱灌注作为辅助治疗，但仍有部分患者对BCG治疗无反应，约50%的患者在5年内发生肿瘤复发。传统上针对复发患者是采用根治性膀胱切除术，但该项手术会使患者失去正常的储尿和排尿功能，严重影响患者的生活质量。因此，对于化疗和BCG无应答NMIBC患者而言，二线治疗的新药研发十分关键。截至目前，全球仅批准三款可用于NMIBC患者的二线疗法，分别是默沙东的K药、Ferring Pharmaceuticals的Adstiladrin和去年4月份刚获得FDA批准的ImmunityBio的Anktiva。不过从其获批适应症上来看，K药以及Adstiladrin仅限于原位癌（CIS），其在NMIBC中占比仅有10%，意味着目前现有获批的二线疗法覆盖的患者群体始终有限。 2024年，可以说是NMIBC治疗领域加速突破的一年。 4月，Anktiva作为ImmunityBio推出的首个基于IL-15的免疫疗法治疗NMIBC，获得了FDA的批准。 8月，UroGen Pharma宣布其丝裂霉素灌注疗法UGN-102已向FDA提交了NDA，用以治疗低级别中等风险非肌层浸润性膀胱癌（LG-IR-NMIBC）患者。试验中，首次使用UGN-102的患者在三个月后，接近80%的人实现了肿瘤完全消失，且12个月后82.3%的患者依然维持无瘤状态。 12月，Protara Therapeutics宣布，其试验性细胞疗法在六个月内对18名对携带高风险原位癌的NMIBC患者的CR率高达72%，在这项积极数据的推动下，公司股价从3.54美元飙升至6.76美元，暴涨119%。同样在12月份，CG Oncology公布了其溶瘤病毒疗法Cretostimogene用于治疗对BCG无应答的高风险NMIBC患者的3期BOND-003试验的主要结果。接受Cretostimogene（CG0070）单药治疗后，近75%的患者在任何时间点达成完全缓解（CR），已计划在2025年下半年向FDA提交上市申请。值得一提的是，2019年，乐普生物获得Cretostimogene（CG0070）中国内地、香港和澳门的开发和商业化权益，目前正在国内开展单药治疗NMIBC临床试验。而国内进展最快的，则是亚虹医药的全球首个进入关键性3期临床试验的NMIBC口服可逆性MetAP2抑制剂APL-1202。在该药物二线NMIBC适应症折戟后，目前正在开展APL-1202另外两项临床试验，分别为APL-1202单药治疗未经治疗的中、危NMIBC的3期临床试验（一线NMIBC适应症）以及APL-1202口服联合PD-1替雷利珠单抗作为MIBC新辅助治疗的2期临床试验。在接二连三的突破性进展之下，NMIBC领域的竞争将愈发激烈。因此对于强生而言，从NMIBC到MIBC深入布局膀胱癌全程化诊疗是其必由之路，目前也初见成效。以TAR-200为例，除了此次提交NDA的单药治疗NMIBC适应症外，强生还设计了一系列研究探索TAR-200单药或联合Cetrelimab（PD-1单抗）治疗NMIBC和MIBC的安全性和有效性，这些研究大都已进行到2/3期，展示出优秀的临床应用前景。此外，强生还有意将厄达替尼拓展到NMIBC领域。厄达替尼虽然在NMIBC患者中显示出了疗效，但全身给药的副作用很大。利用TARIS系统强生如法炮制以膀胱内药物输送系统将厄达替尼在较长时间内、以非常低的剂量持续局部释放到膀胱（TAR-210），完美解决了全身毒性的问题。根据在2024年美国泌尿外科协会年会上报告的一项1期研究的结果显示：TAR-210对具有FGFR基因突变的高风险和中风险非肌层浸润性膀胱癌（NMIBC）患者显示出非常积极的临床活性。在队列1中，90%的患者在12个月时无复发，中位随访时间为8.9个月；在队列3中，31名患者的反应可评估，CR率90%。参考来源 1.https://www.onclive.com/view/fda-approval-sought-for-tar-200-in-bcg-unresponsive-high-risk-nmibc-with-cis. 2.https://www.investor.jnj.com/news/news-details/2025/New-Drug-Application-initiated-with-U.S.-FDA-for-TAR-200-the-first-and-only-intravesical-drug-releasing-system-for-patients-with-BCG-unresponsive-high-risk-non-muscle-invasive-bladder-cancer/default.aspx. 友情推荐：医药行业深度技术内容，点击“博药”查看详情~ 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

临床结果并购临床2期

100 项与 Cetrelimab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11488	-	-	DB15421

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	临床3期	美国	Janssen Research & Development LLC	2023-03-23
非肌层浸润性膀胱肿瘤	临床3期	中国	Janssen Research & Development LLC	2023-03-23
非肌层浸润性膀胱肿瘤	临床3期	日本	Janssen Research & Development LLC	2023-03-23
非肌层浸润性膀胱肿瘤	临床3期	阿根廷	Janssen Research & Development LLC	2023-03-23
非肌层浸润性膀胱肿瘤	临床3期	澳大利亚	Janssen Research & Development LLC	2023-03-23
非肌层浸润性膀胱肿瘤	临床3期	比利时	Janssen Research & Development LLC	2023-03-23
非肌层浸润性膀胱肿瘤	临床3期	巴西	Janssen Research & Development LLC	2023-03-23
非肌层浸润性膀胱肿瘤	临床3期	加拿大	Janssen Research & Development LLC	2023-03-23
非肌层浸润性膀胱肿瘤	临床3期	捷克	Janssen Research & Development LLC	2023-03-23
非肌层浸润性膀胱肿瘤	临床3期	法国	Janssen Research & Development LLC	2023-03-23

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04640623 (SunRISe-1, AUA2023) 人工标引	临床2期	非肌层浸润性膀胱肿瘤	26	TAR-200	範鏇衊築獵鬱繭膚窪齋(遞獵醖淵鹽夢夢壓願衊) = 獵夢鬱鏇鹽遞構艱獵憲網繭淵醖憲鹹繭獵憲醖 (鹽醖廠網衊艱獵衊衊鹽 ) 更多	积极	2023-04-30
				Cetrelimab	範鏇衊築獵鬱繭膚窪齋(遞獵醖淵鹽夢夢壓願衊) = 願顧鑰憲築廠淵鑰膚壓網繭淵醖憲鹹繭獵憲醖 (鹽醖廠網衊艱獵衊衊鹽 ) 更多
NCT02908906 (LUC1001, Pubmed \| Cancer Chemother Pharmacol)	临床1/2期	晚期癌症	413	Cetrelimab 240 mg Q2W	糧壓築築夢壓壓餘鑰夢(簾鑰鏇鹽築膚鑰膚獵廠) = Grade ≥ 3 adverse events (AEs) occurred in 53.9% of patients 膚構選窪築膚餘鏇觸糧 (選鬱蓋襯選膚鹽齋膚繭 ) 更多	积极	2022-03-17
NCT03357952 (Pubmed \| Clin Lymphoma Myeloma Leuk) 人工标引	临床2/3期	多发性骨髓瘤末线	10	Daratumumab+Cetrelimab (safety run-in phase)	構顧夢鹹鏇範膚範網壓(鹹淵艱鏇製網膚積繭衊) = In the safety run-in, 7 (77.7%) patients had ≥ 1 infusion-related reaction (most grade 1-2), and 1 had a grade 2 immune-mediated reaction 範糧膚衊製觸廠膚獵衊 (艱淵窪簾構簾餘鏇觸鹽 ) 更多	不佳	2021-01-01
				Daratumumab+Cetrelimab
NCT03473743 (NORSE, ESMO2020) 人工标引	临床1/2期	尿路上皮癌 FGFR Mutation	22	cetrelimab +erdafitinib	顧鑰衊蓋齋製膚範廠願(構繭廠淵積衊願範襯鹹) = 選鏇鏇獵獵鹹衊鹽齋鹽餘夢壓顧餘醖鏇鹹憲獵 (網獵鹹鏇襯鏇壓製廠餘 ) 更多	积极	2020-09-17
				cetrelimab +erdafitinib	顧鑰衊蓋齋製膚範廠願(構繭廠淵積衊願範襯鹹) = 選淵膚壓膚範積鬱鬱積餘夢壓顧餘醖鏇鹹憲獵 (網獵鹹鏇襯鏇壓製廠餘 ) 更多
NCT02908906 \| NCT03473743 (LUC1001 and NORSE, ASCO2020)	临床1/2期	肿瘤 \| 局部晚期尿路上皮癌	162	Cetrelimab IV 240 q2w	鑰糧廠構醖廠壓製廠網(齋製鹽淵選鑰觸蓋選艱) = Duration of treatment was 8.1 mos (range, 0.0-24.7) for NSCLC; 5.5 mos (range, 0.0-25.0) for MEL; and for 3.0 mos (0.0-16.1) for CRC. 窪膚築鬱餘壓選鹹積製 (齋鹹網鏇網夢廠衊窪夢 ) 更多	-	2020-05-25
NCT03357952 (CTgov)	临床2/3期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	10	Daratumumab+JNJ-63723283 (Part 1: Daratumumab + JNJ-63723283)	鹽鏇衊憲壓築繭膚鏇艱(鬱顧簾壓範鹹鹹夢餘淵) = 衊淵鹹淵簾製繭範廠顧製遞襯願鹽壓鹽築繭憲 (構糧齋積廠範廠鹹鏇廠, 鏇壓壓簾壓鑰網廠鏇觸 ~ 窪蓋壓製膚蓋顧選選製) 更多	-	2019-11-12
				Daratumumab (Part 2: Daratumumab (Arm A))	夢簾觸鑰艱築鹹鏇觸繭(窪艱襯糧廠淵淵鬱憲餘) = 製齋鹹製製餘艱廠獵餘顧網鬱鏇簾糧鬱廠製積 (壓蓋艱憲餘襯製襯獵鬱, 鬱願糧繭選廠鏇膚範夢 ~ 糧製鑰觸窪獵選鑰鏇齋) 更多
EUCTR2016-002017-22-ES (ASCO_SITC2018)	临床1/2期	晚期癌症	32	JNJ-283 80 mg Q2W	遞醖積廠鹹蓋願鹹構蓋(鹹願遞夢鹹鬱膚網網簾) = 衊夢窪築壓構顧繭醖構壓顧鏇觸構襯鏇餘齋選 (積鬱艱積鹽範鑰衊繭遞 ) 更多	积极	2018-01-25
				JNJ-283 240 mg Q2W	遞醖積廠鹹蓋願鹹構蓋(鹹願遞夢鹹鬱膚網網簾) = 窪選壓夢憲鹽廠壓鬱鹹壓顧鏇觸構襯鏇餘齋選 (積鬱艱積鹽範鑰衊繭遞 ) 更多