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更新于：2025-09-13
Ipilimumab biosimilar (Cornerstone)
伊匹木单抗生物类似药(基石药业)
更新于：2025-09-13
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最高研发阶段临床3期 |
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最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
Sequence Code 143797L
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Sequence Code 9060585H
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关联
32
项与 伊匹木单抗生物类似药(基石药业) 相关的临床试验NCT07170995
A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT07110571
A Multi-cohort, Multi-center Phase II Clinical Study of Adebrelimab in Combination With SHR-A1811/SHR-A1904 and Chemotherapy or Adebrelimab in Combination With SHR-8068 as the Treatment in Subjects With Gastric or Gastroesophageal Junction Cancer
NCT07071714
An Open, Multicenter Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer
100 项与 伊匹木单抗生物类似药(基石药业) 相关的临床结果
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100 项与 伊匹木单抗生物类似药(基石药业) 相关的转化医学
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100 项与 伊匹木单抗生物类似药(基石药业) 相关的专利（医药）
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3
项与 伊匹木单抗生物类似药(基石药业) 相关的文献（医药）2024-06-01Cancer
Dual CTLA‐4 and PD‐1 checkpoint blockade using CS1002 and CS1003 (nofazinlimab) in patients with advanced solid tumors: A first‐in‐human, dose‐escalation, and dose‐expansion study
Article
作者: Kotasek, Dusan ; Ma, Yiding ; Aghmesheh, Morteza ; Chan, Stephen L. ; Cosman, Rasha ; Zielinski, Robert ; Mant, Andrew ; Bishnoi, Sarwan ; Moore, Maggie ; Li, Peiqi ; Pan, Zhaoxuan ; Tse, Archie N. ; Yau, Thomas ; Prawira, Amy ; Su, Rila ; Li, Fei ; Eek, Richard
Abstract:
Background:
This study investigated the safety and efficacy of an anti–CTLA‐4 monoclonal antibody (CS1002) as monotherapy and in combination with an anti–PD‐1 monoclonal antibody (CS1003) in patients with advanced/metastatic solid tumors.
Methods:
The phase 1 study involved phase 1a monotherapy dose‐escalation (part 1) and phase 1b combination therapy dose escalation (part 2) and expansion (part 3). Various dosing schedules of CS1002 (0.3, 1, or 3 mg/kg every 3 weeks, or 3 mg/kg every 9 weeks) were evaluated with 200 mg CS1003 every 3 weeks in part 3.
Results:
Parts 1, 2, and 3 included a total of 13, 18, and 61 patients, respectively. No dose‐limiting toxicities or maximum tolerated doses were observed. Treatment‐related adverse events (TRAEs) were reported in 30.8%, 83.3%, and 75.0% of patients in parts 1, 2, and 3, respectively. Grade ≥3 TRAEs were experienced by 15.4%, 50.0%, and 18.3% of patients in each part. Of 61 patients evaluable for efficacy, 23 (37.7%) achieved objective responses in multiple tumor types. Higher objective response rates were observed with conventional and high‐dose CS1002 regimens (1 mg/kg every 3 weeks or 3 mg/kg every 9 weeks) compared to low‐dose CS1002 (0.3 mg/kg every 3 weeks) in microsatellite instability‐high/mismatch repair‐deficient tumors, melanoma, and hepatocellular carcinoma (50.0% vs. 58.8%, 14.3% vs. 42.9%, and 0% vs. 16.7%).
Conclusion:
CS1002, as monotherapy, and in combination with CS1003, had a manageable safety profile across a broad dosing range. Promising antitumor activities were observed in patients with immune oncology (IO)‐naive and IO‐refractory tumors across CS1002 dose levels when combined with CS1003, supporting further evaluation of this treatment combination for solid tumors.
Plain Language Summary:
CS1002 is a human immunoglobulin (Ig) G1 monoclonal antibody that blocks the interaction of CTLA‐4 with its ligands and increases T‐cell activation/proliferation. CS1003, now named nofazinlimab, is a humanized, recombinant IgG4 monoclonal antibody that blocks the interaction between human PD‐1 and its ligands.In this original article, we determined the safety profile of CS1002 as monotherapy and in combination with CS1003. Furthermore, we explored the antitumor activity of the combination in anti–programmed cell death protein (ligand)‐1 (PD‐[L]1)‐naive microsatellite instability‐high/mismatch repair‐deficient (MSI‐H/dMMR) pan tumors, and anti–PD‐(L)1‐refractory melanoma and hepatocellular carcinoma (HCC).CS1002 in combination with CS1003 had manageable safety profile across a broad dosing range and showed promising antitumor activities across CS1002 dose levels when combined with CS1003. This supports further assessment of CS1002 in combination with CS1003 for the treatment of solid tumors.
2017-01-01BMJ open4区 · 医学
Rococo study: a real-world evaluation of an over-the-counter medicine in acute cough (a multicentre, randomised, controlled study)
4区 · 医学
ArticleOA
作者: Edwards, V ; Wilson, R ; Brew, J ; Kilbourn, A ; Morice, A H ; Birring, S S
Objectives:
To investigate the efficacy and safety of CS1002, an over-the-counter cough treatment containing diphenhydramine, ammonium chloride and levomenthol in a cocoa-based demulcent.
Design:
A multicentre, randomised, parallel group, controlled, single-blinded study in participants with acute upper respiratory tract infection-associated cough.
Setting:
4 general practitioner (GP) surgeries and 14 pharmacies in the UK.
Participants:
Participants aged ≥18 years who self-referred to a GP or pharmacist with acute cough of <7 days' duration. Participant inclusion criterion was cough severity ≥60 mm on a 0–100 mm visual analogue scale (VAS). Exclusion criteria included current smokers or history of smoking within the past 12 months (including e-cigarettes). 163 participants were randomised to the study (mean participant age 38 years, 57% females).
Interventions:
Participants were randomised to CS1002 (Unicough) or simple linctus (SL), a widely used cough treatment, and treatment duration was 7 days or until resolution of cough.
Main outcome measures:
The primary analysis was intention-to-treat (157 participants) and comprised cough severity assessed using a VAS after 3 days' treatment (prespecified primary end point at day 4). Cough frequency, sleep disruption, health status (Leicester Cough Questionnaire (LCQ-acute)) and cough resolution were also assessed.
Results:
At day 4 (primary end point), the adjusted mean difference (95% CI) in cough severity VAS between CS1002 and SL was −5.9 mm (−14.4 to 2.7), p=0.18. At the end of the study (day 7) the mean difference in cough severity VAS was −4.2 mm (−12.2 to 3.9), p=0.31. CS1002 was associated with a greater reduction in cough sleep disruption (mean difference −11.6 mm (−20.6 to 2.7), p=0.01) and cough frequency (mean difference −8.1 mm (−16.2 to 0.1), p=0.05) compared with SL. There was greater improvement in LCQ-acute quality of life scores with CS1002 compared with SL: mean difference (95% CI) 1.2 (0.05 to 2.36), p=0.04 after 5 days' treatment. More participants prematurely stopped treatment due to cough improvement in the CS1002 group (24.4%) compared with SL (10.7%; p=0.02). Adverse events (AEs) were comparable between CS1002 (20.5%) and SL (27.6%) and largely related to the study indication. 6 participants (7%) in the CS1002 group reduced the dose of medication due to drowsiness/tiredness, which subsequently resolved. These events were not reported by participants as AEs.
Conclusions:
Although the primary end point was not achieved, CS1002 was associated with greater reductions in cough frequency, sleep disruption and improved health status compared with SL.
Trial registration number:
EudraCT number2014-004255-31.
Frontiers in Immunology
SHR-8068 combined with adebrelimab and bevacizumab in the treatment of refractory advanced colorectal cancer: study protocol for a single-arm, phase Ib/II study
Article
作者: Zhang, Pei ; Wang, Xin ; Yang, Yu ; Wang, Jianfei ; Li, Xiaofen ; Cao, Dan
Background:
The third-line treatment for refractory colorectal cancer (CRC) has limited efficacy. This study aimed to evaluate the safety and efficacy of SHR-8068 (an anti-CTLA-4 antibody), combined with adebrelimab (an anti-PD-L1 antibody), and bevacizumab in refractory non-microsatellite instability-high (MSI-H) or proficient mismatch repair (pMMR) CRC.
Method:
This study is a prospective, open-label, single-center phase Ib/II clinical trial. Patients with pathologically confirmed pMMR/non-MSI-H metastatic colorectal adenocarcinoma who have failed ≥2 lines prior standard systemic treatments will be enrolled (n=36). The Ib phase will evaluate two dosing regimens of SHR-8068 in combination therapy (n=9 each dosage): SHR-8068 (1 mg per kilogram, every six weeks, intravenously) or SHR-8068 (4 mg per kilogram, every twelve weeks, intravenously) combined with adebrelimab (1200 mg, every three weeks, intravenously) and bevacizumab (7.5 mg per kilogram, every three weeks, intravenously). The efficacy and adverse events (AEs) of these regimens will be assessed to determine the recommended phase II dose (RP2D) of SHR-8068. Those of RP2D group from the phase Ib will be included in the phase II. The study will go to include 18 additional patients according to the one-sample log-rank test design in the phase II. The primary endpoint of the Ib phase is safety, with secondary endpoints including the objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and quality of life (QOL). The primary endpoint for phase II was PFS, with secondary endpoints including ORR, OS, DCR, safety, and QOL. Identifying biomarkers to predict the efficacy of this regimen is the exploratory study endpoint.
Discussion:
This proof-of-concept study would provide safety and efficacy signals of this novel combination treatment for the MSS CRCs in the late-line setting. And it may offer new insights on the clinical application of dual immunotherapy combined with anti-angiogenic therapy in the MSS CRC.
71
项与 伊匹木单抗生物类似药(基石药业) 相关的新闻（医药）2025-09-06
临床3期免疫疗法引进/卖出临床申请申请上市
2025-08-24
·信狐药迅
申请上市临床申请临床1期
2025-08-15
·健识局
引进/卖出财报
100 项与 伊匹木单抗生物类似药(基石药业) 相关的药物交易
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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 |
|---|---|---|---|---|
| 局部晚期非小细胞肺癌 | 临床3期 | 中国 | 2025-09-01 | |
| 转移性非小细胞肺癌 | 临床3期 | 中国 | 2025-09-01 | |
| 晚期肝细胞癌 | 临床3期 | 中国 | 2024-10-28 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2024-03-01 | |
| 胃食管交界处癌 | 临床2期 | 中国 | 2025-08-01 | |
| 大肠腺癌 | 临床2期 | 中国 | 2025-07-22 | |
| 宫颈癌 | 临床2期 | 中国 | 2025-04-25 | |
| HER2阳性胆道肿瘤 | 临床2期 | 中国 | 2025-02-26 | |
| 晚期恶性实体瘤 | 临床2期 | 中国 | 2025-02-18 | |
| 晚期尿路上皮癌 | 临床2期 | 中国 | 2024-11-04 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | - | 積積繭蓋窪製襯壓鏇製(積鏇範齋襯壓範鬱網積) = TRAE led to discontinuation of any study agent in 11.1%, 1.9% and 9.5% of pts for Combo 1, 2, and 3, respectively 獵襯選積窪遞夢選選範 (餘壓醖範壓齋衊願餘鑰 ) 更多 | 积极 | 2025-05-30 | |||
临床1期 | 36 | 鏇顧繭糧顧衊憲鏇鑰廠(糧窪窪淵鑰膚鏇顧鹽壓) = 5 (9.3%) pts had AEs leading to discontinuation of CS1002 and CS1003. 壓襯顧齋鑰憲鹹鹽壓願 (簾築築夢糧鏇艱觸選選 ) 更多 | 积极 | 2021-12-09 | |||
临床1期 | 33 | CS1003 200 mg+CS1002 0.3 mg/kg | 廠選積鬱憲膚醖齋繭繭(鹽選築鹽製蓋鏇遞觸選) = Two (6.1%) pts experienced AEs leading to discontinuation of CS1002 and CS1003. 獵構選積鑰壓鑰廠積鏇 (簾鏇餘廠鑰鬱觸糧積獵 ) | 积极 | 2021-09-16 | ||
CS1003 200 mg+CS1002 1 mg/kg |
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