A Phase Ib/II, Multicenter, Open-label, Single-arm Study to Assess the Safety and Efficacy of GFH009 in Combination With Zanubrutinib in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

开始日期2024-03-20

申办/合作机构

劲方医药科技（上海）股份有限公司

NCT05934513

/ Recruiting临床1/2期

A Phase Ib/II, Multicentre, Open-label Study to Assess the Efficacy, Safety/ Tolerability and Pharmacokinetic of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the efficacy, safety/ tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma

开始日期2023-09-06

申办/合作机构

劲方医药科技（上海）股份有限公司

NCT04588922

/ Recruiting临床1/2期

A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies and High-Risk Newly Diagnosed AML

SLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with relapsed/refractory AML, Group 2 in patients with relapse/refractory lymphoma/CLL/SLL). The safety, tolerability, and antitumor activity of SLS009 in combination with venetoclax and azacitidine in patient with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five cohorts of the expansion Group 3. Groups 4 and 5 have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine in newly diagnosed AML patients who are less likely to benefit from standard induction treatment with venetoclax plus HMA only regimens.

开始日期2021-05-10

申办/合作机构

SELLAS Life Sciences Group, Inc.

100 项与 Tambiciclib 相关的临床结果

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100 项与 Tambiciclib 相关的转化医学

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100 项与 Tambiciclib 相关的专利（医药）

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项与 Tambiciclib 相关的文献（医药）

2024-11-25·XENOBIOTICA

Preclinical metabolism and disposition of [ ¹⁴ C]GFH009, a novel selective CDK9 inhibitor

Article

作者: Zhao, Jin-Zhu ; Lan, Jiong ; Wang, Li ; Lu, Qiang ; Zhou, Fu-Sheng ; Ren, Hong-Can

GFH009 is a potent and highly selective cyclin-dependent kinase 9 (CDK9) inhibitor currently under phase II clinical trials. In this study, we investigated the metabolism and disposition of GFH009 in Sprague-Dawley (SD) rats, as well as in vitro metabolism of CD-1 mouse, SD rat, beagle dog, cynomolgus monkey, and human.A radiolabelled study indicated that [¹⁴C]GFH009 was quickly and widely distributed throughout the body, but presented low levels in brain, testis, and epididymis after a single intravenous dose of 6 mg (100 µCi)/kg to SD rats.GFH009 undergoes systemic metabolic changes, primarily through O-demethylation, oxidation to carboxylic acid and N-dealkylation, cleavage off the methoxyisopropyl moiety being a minor pathway. These metabolic pathways were found to be mainly consistent both in vitro and in vivo.In SD rats, GFH009 was rapidly and completely eliminated, with faeces serving as the major excretion pathway and urine serving as the minor one. Besides, the major clearance pathway for GFH009 was excretion and the minor one was metabolism.GFH009 exhibits favourable drug metabolism and pharmacokinetics (DMPK) properties, which provides valuable insights into the disposition of GFH009 and can be used to guide future clinical studies.

2024-02-01·Biomedical chromatography : BMC

Development and validation of a sensitive UPLC–MS/MS analytical method for GFH009 in rat plasma and its application to toxicokinetics studies

Article

作者: Zhou, Fu‐Sheng ; Ren, Hong‐Can ; Lan, Jiong ; Zhao, Jin‐Zhu ; Lu, Qiang ; Liu, Qiang

Abstract:

GFH009 is a potent, highly selective, small molecule that targets and inhibits the activity of the CDK9/cyclin T1 regulatory complex of P‐TEFb. This study aimed to develop and validate a highly selective and sensitive ultrahigh‐performance liquid chromatography–tandem mass spectrometry (UHPLC–MS/MS) method for precise quantification of GFH009 in rat plasma. This method was subsequently employed for conducting toxicokinetic studies of GFH009 in rats. Plasma was prepared using a simple protein precipitation method by acetonitrile. Chromatographic separation of the analytes was achieved on a BEH C18 analytical column with a rapid 3.0 min run time and a flow rate of 0.5 ml/min. The calibration curves for plasma samples exhibited excellent linearity over a wide concentration range of 1.0–1,000 ng/ml for GFH009. Intra‐ and inter‐day accuracies were within 92.7–105.7%, and precisions were no more than 6.7%. Furthermore, the analyte demonstrated stability under four different storage conditions, with variations of <15.0%. This study pioneers a methodological innovation by introducing a highly reliable, specific and sensitive analytical method for GFH009 in rat plasma. The successful application of this method in toxicokinetic studies further underscores its significance, offering valuable insights for the methodology of clinical pharmacokinetic research.

2022-10-01·Clinical Lymphoma Myeloma & Leukemia

AML-259 Pharmacokinetics and Bioequivalence of Two Formulations of GFH009 Maleate Injection in Sprague Dawley Rats

Article

作者: Zhou, Fusheng ; Lan, Jiong ; Cicic, Dragan ; Lu, Qiang ; Zhao, Jinzhu

CONTEXT:

Cyclin-dependent kinase 9 (CDK9) is a serine/threonine kinase that regulates the expression of short-lived oncogene products, such as MYC and MCL1, which are key influencers of tumor cell proliferation and survival. CDK9 deregulation has been reported in leukemia and other hematological malignancies. GFH009 is a potent, highly selective, clinical-stage, small molecule that inhibits CDK9.

OBJECTIVE:

The objective of this study was to characterize the preclinical pharmacokinetic (PK) profiles of two different formulations of GFH009 maleate (pH 4.5 and 6.0).

DESIGN AND MAIN OUTCOME MEASURES:

Sprague Dawley (SD) rats were randomized to receive a single dose of one formulation of GFH009 maleate (4 mg/kg) intravenously (IV) at a volume of 5 mL/kg. Blood samples were obtained at pre-dose and pre-specified timepoints post-dose. Plasma concentration of GFH009 was quantitated by a validated LC-MS/MS method, and PK parameters were assessed by non-compartmental analysis approach.

RESULTS:

Twelve SD rats per group were included. The plasma concentrations of the GFH009 formulations were within 90% to 110% of the nominal concentrations, and the coefficient of variation was <5.0%. The mean plasma concentration peaked at 5 min post-dose (479 ng/mL and 486 ng/mL in groups 1 and 2, respectively) and gradually decreased in a similar profile. The LLOQ was 1.000 ng/mL. In group 1, C0 (mean ± SD) was 586 ± 109 ng/mL, AUClast was 825 ± 73.8 h-ng/mL; AUCInf was 842 ± 75.0 h-ng/mL, clearance (CL) was 4780 ± 429 mL/h/kg, and t1/2 was 5.45 ± 0.649 h. In group 2, C0 was 572 ± 147 ng/mL, AUClast was 924 ± 144 h-ng/mL, AUCInf was 946 ± 145 h-ng/mL, CL was 4310 ± 607 mL/h/kg, and t1/2 was 5.66 ± 0.973 h. Bioequivalence analysis showed that the 90% CI values for C0, AUClast, and AUCInf were within the acceptable range (80-125%).

CONCLUSIONS:

The PK profiles of GFH009 were comparable following single IV administration of two formulations of GFH009 maleate injection in SD rats, which supported application of the pH 6.0 formulation in Phase I trials in patients with relapsed/refractory hematologic conditions, including AML and lymphoma.

175

项与 Tambiciclib 相关的新闻（医药）

2026-03-16

·GlobeNewswire-Health Care

SELLAS Life Sciences Announces Enrollment of First Patient in Newly Diagnosed First-Line AML Trial of SLS009

- Study to Enroll 80 Patients Unlikely to Benefit from Venetoclax/Azacitide (Aza/Ven) Therapy in the US and Europe - - SELLAS’ Predictive Biomarker and AI Assisted Precision Medicine Models to be Utilized - - Topline Data Expected in Q4 2026 – March 12, 202 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced the first patient has been enrolled in its randomized Phase 2 trial evaluating SLS009 (tambiciclib), a highly selective CDK9 inhibitor in newly diagnosed, first-line acute myeloid leukemia (AML) patients. The newly initiated NCT04588922 is designed to enroll approximately 80 patients and includes two AML cohorts with high unmet need and greatest potential benefit: Predictive biomarker cohort: Newly diagnosed patients unlikely to benefit from standard aza/ven therapy based on molecular profiling Early resistance cohort: Patients who initiate treatment with aza/ven but demonstrate a confirmed lack of any response after two treatment cycles “Enrolling the first patient in this first-line AML Phase 2 study represents an important milestone in the advancement of our SLS009 program and reflects our precision medicine strategy to address challenging subgroups of AML patients through our extensive transcriptomics, genomics, and proteomics models we have established,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “The strength of our Phase 2 data in r/r AML, particularly in high-risk molecular subtypes, together with the FDA's guidance, provided a strong foundation for moving into earlier lines of therapy. By targeting molecularly defined subgroups and those demonstrating early non-response, we aim to address a critical need in frontline AML and position SLS009 for potential registrational development.” This milestone follows the Company’s previously reported positive Phase 2 results in relapsed/refractory (r/r) AML and the FDA’s guidance recommending advancement into a study that includes newly diagnosed AML patients eligible for venectoclax and azacitidine (aza/ven) therapy. In the completed Phase 2 trial in r/r AML, SLS009 in combination with aza/ven met all endpoints, exceeding the pre-specified ORR threshold of 20%, demonstrating strong efficacy and favorable safety and tolerability with robust anti-tumor activity: 33% overall response rate (ORR) in all evaluable patients across all cohorts and dose levels, and 40% ORR for the recommended 30mg BIW dose level. ORR of 44% in AML patients with myelodysplasia-related changes (AML-MR) at the 30mg BIW dose ORR of 50% in ASXL1-mutated AML-MR at 30 mg BIW dose levels and 50% ORR in M4/M5 subtypes Median overall survival (mOS) of 8.8 months in patients treated with 30mg BIW, with a median of 1 prior line of therapy, and mOS of 8.9 months in AML MR patients vs 2.4 months with best available therapy. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. The content above comes from the network. if any infringement, please contact us to modify.

临床结果

2026-03-06

·龙谈价值2023

港股通调整，哪些公司值得关注

大家好，我是龙哥。不知不觉又临近港股通名单调整的时间，今天收盘后港股通调整，下周一开盘前正式生效。上一次某些庄股借助港股通名单调整和ETF持仓调整割韭菜的行为似乎还近在眼前，当时的分析文章《坏了，药捷安康的瓜吃到自己头上了》有讨论这个问题，本次港股通调整，也是风险与机遇并存，有些公司又被坐庄，磨好镰刀准备收割我们，还有些质地好一些的公司，入通后也是给没有港股账户的投资人们买入的机会。本次港股通调整涉及的医药公司还是比较多的，主要是去年港股新上市了不少公司《创新药港股IPO大爆发》，不管是公司本身质地还可以、或者是因为流通盘小而估值有溢价，总之是数量和占比还是比较高的。本次新纳入港股通的有以下公司：英矽智能、中慧生物、宝济药业、派格生物、劲方生物、轩竹生物、康臣药业、科济药业、海西新药、长风药业、维立志博。 1、值得关注的公司 ①英矽智能英矽智能是国内AI制药领域双龙头之一，另一家大家应该也都知道——晶泰控股，目前市值也不小。英矽智能与晶泰控股的商业模式均介乎创新药biotech与CRO公司之间，相对来说英矽智能与和铂医药更加接近，也即更偏向创新药biotech的商业模式，而晶泰控股更加偏向CRO的商业模式。英矽智能的竞争优势主要包括两块：①借助优秀的生成式人工智能平台Pharma.AI进行药物研发，从靶点发现到临床前候选药物确认时间12-18个月（VS传统研发模式平均4.5年左右）。②其拥有行业顶级的数据量，自2014年开始积累的1000万组数据，其中包括10%的自动化实验室生成的数据。业务结构来看：公司主要有3块业务： i.创新药开发及BD授权，公司开发一系列创新药管线，其中个别最核心管线会选择自己独立往后期开发以最大化收益，其他临床前和I期管线会选择授权给国内外公司——biotech的BD授权模式，公司目前收入80%以上来自BD授权收入。公司自2022年以来达成6笔海外BD交易，还有部分国内的BD交易如在1月底与齐鲁制药达成的9.3亿港元的代谢领域药物开发合作。 ii.创新药CRO服务，基于AI药物发现平台为MNC提供临床前CRO服务，收入占比10%左右，也为沙特石油企业、医美企业等非制药领域提供材料开发服务。 iii.授权使用AI软件，托管订阅费20万美元/年，本地部署订阅费52.5万美元/年，收入占比中高个位数，这几年占比都在5%-10%左右。公司目前在研管线有30+个项目，其中包括10个IND批件，055（TNIK，特发性肺纤维化，对标尼达尼布全球40亿美金销售额）和5411（PHD1/2，IBD适应症，300亿美金潜在市场）两个分子自主推进I/II期临床，其中055预计26H1推进到中国IIb/III期临床，预计国内入组50-70人，3年完成临床，可能2029年申报上市。 AI制药公司的问题也很直接——估值比较难给，在中早期发展阶段叠加资产稀缺性，估值可能持续维持大部分理解不了的较高水平。 ②维立志博在前阵子的文章《超级大药，群雄逐鹿》中我们梳理了第二代IO双抗目前的全球研发进展，维立志博的LBL-024奥帕替苏米单抗是25年下半年开始被大家关注到的一个具有第二代IO潜力的新靶点。公司今年在5月份的研发日、6月份的ASCO以及下半年的研发日和ESMO都会有数据更新，PD-L1*4-1BB双抗在NSCLC的II期临床入组速度超预期，200多人的大II期临床从25年7月开始入组，到26年中前后应该可以入组完，26年5月的研发日会更新更多患者的ORR数据，到四季度可能读出初步PFS率的数据。公司目前有2款药物实现海外授权，为自免领域的双融合蛋白、三抗，分别是LBL-047（BDCA2*TACI）和LBL-051（CD19*BCMA*CD3），051在2024年11月以3500万美元首付款+5.79亿美元里程碑付款授权给Oblenio Bio，047在2025年10月以3800万美元首付款+9.62亿美元里程碑付款授权给Dianthus Therapeutics。另外维立志博还有2款TCE双抗进入临床阶段，分别是LBL-034（GPRC5D*CD3）和LBL-033（MUC16*CD3），LBL-034和上文提到的LBL-024双抗是公司今年做创新药海外BD的重点。 ③劲方医药劲方的管线以肿瘤领域为主，管线主要包括RAS通路的GFH925（KRAS G12C，国内已获批二线NSCLC，国内商业化权益授权给信达生物）、GFH375（KRAS G21D，国内已启动二线PDAC的III期临床）、GFH276（Pan-RAS，I/II期临床剂量爬坡）、GFH784（EGFR-panRAS ADC，IND阶段），以及非RAS通路的GFS202A（GDF15/IL-6，用于肿瘤恶病质,II期临床）、GFH009（CDK9，用于AML，II期临床）、GFH018（TGF-βR1）。 KRAS G12C国内才刚开始商业化放量，已经有劲方/信达、加科思/艾力斯、益方生物/中国生物制药三家公司同时进入医保放量，2月底国内又批了一家济民可信，该靶点在国内的发病率不高，本身市场容量没有非常大，目前进入4家竞争，可能带来的利润和估值可能都会比较有限。 KRAS G12D的全球开发目前普遍处于早期临床，目前全球有恒瑞医药的HRS-4642于25年10月启动联合化疗一线治疗KRAS G12D突变的PDAC的中国III期临床，劲方医药的GFH375此前ESMO读出II期临床数据、于25年11月启动单药二线治疗KRAS G12D突变PDAC的中国III期临床。劲方医药在2025年10月底ESMO披露二线PDAC的II期临床数据，66例二线及以上KRAS G12D阳性PDAC患者的mPFS为5.52个月，三线治疗的mPFS也是5.52个月，好于Revolution的RMC-6236在三线及以上患者的PFS4.4个月（pan-RAS抑制剂，3L+患者群体，不完全可比）。三级以上TRAE发生率31%（公司表示国内PD-1在PDAC渗透率较高，影响后线安全性）VS RMC-6236三级以上TRAE发生率34%。 KRAS G12D全球新发患者群体约为肺癌8.7万人、结直肠癌24万人（欧美日约10万人），胰腺癌18万人（欧美日约7万+），合计新发患者群体51万人、欧美日约20万+，中国患者群体约为12万人（肺癌1.2万+结直肠癌6.4万+胰腺癌4.4万）。市场大头肯定还是在欧美日，国内市场目前是恒瑞、劲方在前排竞争，并且未来也要和pan RAS/pan KRAS竞争。劲方在pan-RAS抑制剂的全球开发进度靠前，目前在进行I期临床剂量爬坡，算是个Revolution的fast follow，Revolution目前市值198亿美元，此前曾传MNC多家有意向收购RVMD，其中最高的估值高达300亿美金，估值对标的天花板比较高，且去年以来市场对RAS通路关注度相对较高， 25年12月加科思的pan KRAS抑制剂授权阿斯利康时的交易对价有些低于市场预期，导致加科思和劲方的估值都有所下跌，但RAS通路的市场潜力还是值得长期关注的。 ④康臣药业公司核心产品是治疗慢性肾病的中成药尿毒清颗粒，2024年的销售规模在18-19亿元，预计2025年维持20%+的高增长到23-24亿元，尿毒清是国家医保目录甲类产品，日用药费用又只有十几块钱，价格比较低，在临床使用比较广泛，近年增长趋势也一直较好，肾科中成药领域没有比较有竞争力的竞品。肾科药物占康臣药业的收入比重在70%左右。康臣药业2025H1收入15.69亿元+23.6%，归母净利润4.98亿元+24.64%，经营现金净流量4.93亿元+40.65%，表观估值是12.6倍PE，总市值125亿元，另外截至2025中报还有38亿元的在手现金。公司在2024年和2025H1都是51%的股利支付率，预计全年计算的股息率大概4%出头，另外公司还在回购股份，近一年累计回购1368万股，占总股本1.61%，回购金额1.85亿元，回购密集出现在25年10月-12月股价回调之际，近期进入了年报披露的静默期，不能回购股份。 2、镰刀互割的公司 ①宝济药业看研发管线基本是没多少机构关注的公司，IPO价格26.38港元/股，发行估值86亿港元已经不低，股价最高炒到206港元，估值高达630亿港元，目前估值仍有456亿港元。去年药捷安康、映恩生物等公司的炒作，是炒到进通、等到指数和ETF调整成份股后拉爆股价并卖给ETF，吃一堑长一智，今年很难再以同样的套路收割ETF基金，因此这类坐庄资金在港股通调整之前提前挥下镰刀互割，在港股通调整前夕还在暴跌。 ②轩竹生物研发管线中虽然有3款创新药获批上市，但PPI、CDK4/6、ALK都是国内严重重复研发和低效内卷的靶点，商业化空间存疑，发行估值60亿港元尚且不算便宜，估值最高炒到500亿港元，目前仍有262亿港元，同样也是没等到港股通调整就开始镰刀互割。其他公司，如海西新药也是提前开始镰刀互割，也有中慧生物、派格生物等至今较为坚挺的。待到限售股解禁时，自然能看清谁在裸泳。 ...... 前期港股大跌，我们找了很多原因，其中一个小的因素，就是港股通调整临近，可能会有投资人担心再出现类似去年9月药捷安康事件导致的ETF亏损，如果做提前赎回ETF规避风险，反而导致头部公司也被动净卖出而下跌。不论今年的港股通调整后是否还会出现如去年9月那样戏剧性的场景，终归是该来的要来了，港股通调整后，风险与机会并存。风险提示：本文仅讨论行业/公司经营情况，投资需综合考虑公司经营、估值、管理层等多方面因素，建议读者审慎参考，本文不作为投资依据，不建议大家根据本文做出投资计划。

IPO临床申请

2026-01-17

·GlobeNewswire-Health Care

SELLAS Life Sciences Enters Agreement with IMPACT-AML to Expand SLS009 Clinical Program into Europe

Supports capital-efficient expansion of the SLS009 clinical program into frontline AML, enabling broader U.S. and European patient enrollment U.S. enrollment evaluating SLS009 in combination with AZA/VEN in newly diagnosed AML with high-risk features is planned for Q1 2026, with European enrollment anticipated in Q2 2026 Jan. 14, 2026 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that it has entered into an agreement with IMPACT-AML, a European collaborative initiative dedicated to advancing innovative treatments for patients with acute myeloid leukemia (AML). Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, a highly selective CDK9 inhibitor, enabling access to multiple European clinical sites and patients. IMPACT-AML is a pan-European project and builds an inclusive clinical network (STREAM platform) that connects patients, clinicians, and researchers to test novel AML therapies and improve patient outcomes (https://impactaml.eu/). It is part of the prestigious EU Mission Cancer program and a top-tier scientific cluster. The IMPACT-AML project is led by a consortium of major research and clinical institutions in Europe, including IRST (IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori”), the University of Bologna, IIS LA FE (Health Research Institute Hospital La Fe), several European AML collaborative groups, and supranational organizations under the umbrella of the European Leukemia Net (ELN), as well as various university hospitals across Europe. By leveraging IMPACT-AML’s existing infrastructure and expertise, SELLAS expects to expand European patient access to SLS009 in a highly cost-efficient manner while supporting broader participation across the clinical program. “This is a highly meaningful milestone for SELLAS and for the SLS009 program,” said Angelos Stergiou, M.D., Sc.D., President and Chief Executive Officer of SELLAS. “Gaining access to the IMPACT-AML framework represents strong external validation of SLS009 and reflects the growing recognition of SLS009’s potential in addressing critical unmet needs in AML. Importantly, this collaboration allows us to efficiently expand our clinical program into Europe by leveraging an established infrastructure, significantly improving capital efficiency while supporting broader and faster patient enrollment as we advance the program into frontline AML.”The collaboration is expected to support the continued execution of the SLS009 clinical program as SELLAS advances into frontline AML. The study in Europe is planned to enroll approximately 40 patients to evaluate SLS009 in combination with azacitidine and venetoclax (AZA/VEN) in patients with newly diagnosed AML with high-risk features. Enrollment in the first part of the trial for newly diagnosed patients is expected to begin at U.S. sites in Q1 2026, followed by initiation at European sites in Q2 2026, subject to regulatory and site readiness. “IMPACT-AML is committed to accelerating access to promising new therapeutic approaches for patients with AML who face limited treatment options,” said IMPACT-AML Scientific Coordinator, Dr. Giovanni Martinelli. “We are pleased to collaborate with SELLAS and support the evaluation of SLS009 within our European network, consistent with our mission to facilitate efficient, high-quality clinical research in AML.” SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. The content above comes from the network. if any infringement, please contact us to modify.

临床研究

100 项与 Tambiciclib 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
复发性弥漫性大B细胞淋巴瘤	临床2期	中国	劲方医药科技（上海）股份有限公司	2024-03-20
难治性弥漫性大 B 细胞淋巴瘤	临床2期	中国	劲方医药科技（上海）股份有限公司	2024-03-20
外周T细胞淋巴瘤	临床2期	中国	劲方医药科技（上海）股份有限公司	2023-09-06
伴有骨髓发育不良相关变化的急性髓系白血病	临床2期	美国	SELLAS Life Sciences Group, Inc.	2021-05-10
伴有骨髓发育不良相关变化的急性髓系白血病	临床2期	中国	SELLAS Life Sciences Group, Inc.	2021-05-10
急性髓单核细胞白血病	临床2期	美国	SELLAS Life Sciences Group, Inc.	2021-05-10
急性髓单核细胞白血病	临床2期	中国	SELLAS Life Sciences Group, Inc.	2021-05-10
急性早幼粒细胞白血病	临床2期	美国	SELLAS Life Sciences Group, Inc.	2021-05-10
急性早幼粒细胞白血病	临床2期	中国	SELLAS Life Sciences Group, Inc.	2021-05-10
淋巴母细胞淋巴瘤	临床2期	美国	SELLAS Life Sciences Group, Inc.	2021-05-10

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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


NCT04588922 (GlobeNewswire) 人工标引	临床2期	急性髓性白血病	-	SLS009 + Venetoclax + Azacitidine	艱繭衊鏇願鑰壓夢構衊(糧夢顧廠鬱餘膚艱獵範) = 遞醖繭鹽膚構蓋鬱顧憲鑰繭積齋鑰顧選艱簾蓋 (淵鏇鑰簾壓窪觸膚醖衊 ) 更多	积极	2025-07-15
				SLS009 30mg BIW + Venetoclax + Azacitidine	艱繭衊鏇願鑰壓夢構衊(糧夢顧廠鬱餘膚艱獵範) = 製獵壓艱鑰築繭夢蓋獵鑰繭積齋鑰顧選艱簾蓋 (淵鏇鑰簾壓窪觸膚醖衊 ) 更多
NCT04588922 (GlobeNewswire) 人工标引	临床2期	急性髓性白血病 \| 伴有骨髓发育不良相关变化的急性髓系白血病	14	SLS009 + venetoclax/azacitidine (r/r AML)	鹽醖鏇鹹遞衊範築鹹憲(憲鏇醖廠構壓艱積襯餘) = 繭鏇範鏇醖鏇蓋觸淵襯衊鑰願鑰製簾顧願獵鏇 (窪鬱鏇壓糧積範齋遞鏇 ) 更多	积极	2025-04-08
				SLS009 + venetoclax/azacitidine (AML MRC)	鹽醖鏇鹹遞衊範築鹹憲(憲鏇醖廠構壓艱積襯餘) = 醖衊餘顧夢糧繭鑰夢醖衊鑰願鑰製簾顧願獵鏇 (窪鬱鏇壓糧積範齋遞鏇 ) 更多
NCT06375733 (Company_Website) 人工标引	临床2期	弥漫性大B细胞淋巴瘤	9	SLS009 (tambiciclib) in combination with Zanubrutinib	願構淵廠艱製鏇衊選糧(鹽鏇窪襯齋製觸鏇鑰醖) = 憲鏇壓餘餘簾積襯壓遞簾願廠餘夢鹹築艱製製 (糧範繭鬱願鹹夢鏇夢構 ) 更多	积极	2025-02-20
				SLS009 (tambiciclib) in combination with Zanubrutinib (Difficult-to-Treat Non-GCB)	廠選壓顧簾醖鑰鬱網餘(顧蓋鬱網衊選鏇製構築) = 構簾鹹淵鑰廠構鹽積鬱鹽鹽選淵夢糧壓範網憲 (壓淵膚繭選鬱窪鹽繭構 )
NCT04588922 (GlobeNewswire) 人工标引	临床2期	急性髓性白血病 ASXL1 Mutation	-	SLS009 30 mg BIW	蓋築醖壓築築衊鏇夢鹹(構簾網餘繭窪觸築築鬱) = 壓廠網醖憲觸醖夢廠蓋夢艱願壓鏇壓製廠齋鑰 (膚鬱網簾鏇簾範製簾願 )	积极	2024-12-09
				SLS009 (AML MRC)	艱壓糧網衊鏇築觸願遞(淵糧顧觸獵窪顧淵襯鑰) = 襯憲窪鑰願齋簾簾鏇範選壓淵鏇願鏇膚簾顧衊 (獵製膚淵憲網鹹繭壓糧 )
ASH2024	N/A	急性髓性白血病	-	SLS009 45 mg QW	繭鏇願艱簾顧窪築鏇顧(築襯繭簾艱構築觸繭繭) = Drug related toxicities of any grade occurring in more than one patient across all cohorts were nausea (23%), diarrhea (13%), hyperphosphatemia (10%), pyrexia (7%) and white blood cell count decreased (7%) 艱鹹鬱鹽鹽網繭構夢艱 (醖衊壓願艱醖繭膚製廠 ) 更多	-	2024-12-08
				SLS009 60 mg QW
NCT04588922 (GlobeNewswire) 人工标引	临床2期	急性髓性白血病	30	SLS009 30 mg BIW	鬱襯糧憲淵壓遞壓糧選(鏇衊鏇膚觸餘鏇餘衊壓) = none 齋鬱觸構製壓壓醖繭範 (艱範壓衊廠醖鹽範壓淵 )	积极	2024-06-10
				SLS009 45 mg QW
NCT04588922 (GlobeNewswire) 人工标引	临床1/2期	急性髓性白血病 ASXL1 Mutation	-	GFH009+venetoclax+azacitidine	鑰齋積衊窪簾製鹽淵醖(餘窪襯獵鏇壓選觸鬱餘) = 衊願襯淵築範築齋艱築衊壓衊齋襯醖獵製簾觸 (糧構繭夢製製網鏇鹹壓 ) 更多	积极	2024-05-01
NCT04588922 (GlobeNewswire) 人工标引	临床2期	急性髓性白血病	21	SLS009 45 mg+azacitidine+venetoclax	齋鏇鹽夢餘衊窪範鏇簾(淵襯築鬱壓齋選餘淵鏇) = 淵鑰夢範觸範壓繭廠糧製淵窪鑰艱壓繭積鏇築 (遞餘製淵顧膚鹹願積蓋 )	积极	2024-03-26
				SLS009 60 mg QW+azacitidine+venetoclax	齋鏇鹽夢餘衊窪範鏇簾(淵襯築鬱壓齋選餘淵鏇) = 選鬱網鬱製襯鑰選鹹鏇製淵窪鑰艱壓繭積鏇築 (遞餘製淵顧膚鹹願積蓋 )
CTR20210356 (Biospace) 人工标引	临床1期	外周T细胞淋巴瘤	-	SLS009	積鹽範鏇壓淵憲窪衊構(餘淵積範網築願襯網鹹) = 餘鹹遞壓鏇繭選艱壓蓋願構遞醖繭選艱餘窪鹽 (築選餘構憲顧範構顧蓋 )	积极	2023-12-21
				belinostat	積鹽範鏇壓淵憲窪衊構(餘淵積範網築願襯網鹹) = 網築積襯夢齋襯壓膚蓋願構遞醖繭選艱餘窪鹽 (築選餘構憲顧範構顧蓋 )
NCT04588922 (Biospace) 人工标引	临床1期	血液肿瘤	11	SLS009	蓋壓廠膚淵廠醖範餘遞(窪積衊構鬱願齋鏇壓淵) = 淵鹽鹽遞繭糧願簾糧齋齋範築鏇築醖鬱構鏇鹹 (糧廠遞窪糧積鑰簾獵鹹 )	积极	2023-10-30