NCT07252414招募中1 期
A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants With Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 9
- 主要终点
- Part 1 and Part2:Incidence of adverse events Percentage of patients with adverse events by system organ class and preferred term.
研究概览
简要总结
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors
详细描述
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the ICF.
- •Male or female participants ≥18 years old at the time of signing the ICF.
- •Meet the requirements of tumor types as outlined below:
- •Dose escalation: Participants with histologically or cytologically documented recurrent or metastatic advanced solid tumors, and who have progressed after standard therapy, are intolerant to standard therapy, or have no standard therapy available.
- •Dose expansion:
- •Cohort 1: Participants with histologically or cytologically documented mCRPC，who had received at least one prior novel hormonal therapy (including but not limited to abiraterone, enzalutamide, darolutamide, apalutamide) and progressed on standard chemotherapy regimens, are intolerant to chemotherapy, or decline chemotherapy.
- •Cohort 2: Participants with histologically or cytologically documented other advanced solid tumors, and who have progressed after standard therapy, are intolerant to standard treatment, or have no standard therapy available.
- •Life expectancy of ≥ 12 weeks.
- •ECOG PS 0-1
- •Have at least 1 evaluable tumor lesion according to RECIST v1.
- •Participants with mCRPC who have bone only disease may be eligible on a case-by-case basis after discussion between the investigator and Sponsor
- •Able to provide either archival or fresh biopsy formalin-fixed paraffin-embedded (FFPE) tumor samples.
- •Adequate organ function at the time of screening, as outlined below:
- •Hematology: Absolute neutrophil count (ANC) ≥ 1.5×109/L (1500/µL); platelet count (PLT)≥100×109/L (100,000/µL); hemoglobin (HGB) ≥ 90 g/L (9 g/dL) (have not received granulocyte colony-stimulating factor (G-CSF) within 7 days before the first dose of GenSci143, and have not received granulocyte-macrophage colony-stimulating factor (GM-CSF), blood transfusion, erythropoietin (EPO), platelet transfusion, thrombopoietin (TPO), or interleukin-11 (IL-11) within 14 days before the first dose of GenSci143).
- •Liver function: Serum total bilirubin (TBIL) ≤ 1.5 upper limit of normal (ULN), and serum TBIL≤ 3×ULN in the presence of liver metastasis or documented Gilbert syndrome. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN if no liver metastasis; ALT and AST≤ 5×ULN in the presence of liver metastasis.
- •Renal function: creatinine clearance (CLcr) ≥ 50 mL/min as calculated using the Cockcroft-Gault formula.
- •Coagulation function: Prothrombin Time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (or within target range if on anticoagulation therapy).
- •Toxicities (other than alopecia) from previous anticancer therapy must have resolved to NCI-CTCAE v5.0 Grade ≤
- •Women of childbearing potential (WOCBP) must have a serum pregnancy test negative within 7 days before the first dose of GenSci
- •WOCBP must agree to use highly effective contraceptive methods and must not donate or retrieve ova for personal use from the time of informed consent until 6 months after the last dose of GenSci
- •Male participants must agree to use highly effective contraceptive methods and must not freeze or donate sperm from the time of informed consent until 6 months after the last dose of GenSci143.
排除标准
- •Participants with known spinal cord compression or active central nervous system (CNS) metastases, unless they are asymptomatic or have achieved post-treatment stability for >4 weeks and discontinued corticosteroids for >2 weeks before the first dose of GenSci
- •History of other known malignancies within the past 3 years.
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose of GenSci
- •Uncontrolled or clinically significant cardiovascular disease.
- •Uncontrolled pleural fluid, pericardial effusion, or ascites requiring drainage, and/or diuretics within 2 weeks before the first dose of GenSci
- •History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. Any autoimmune, connective tissue, or inflammatory disorders with suspected pulmonary involvement.
- •Pregnant, breastfeeding, or planning to become pregnant.
- •Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Known human immunodeficiency virus (HIV) infection
- •Uncontrolled infection that requires systemic therapy with IV antibiotics, antivirals, or antifungals within 1 week before the first dose of GenSci
- •Major surgery (excluding diagnostic surgery), radiotherapy, and immunotherapy within 4 weeks before the first dose of medication; Chemotherapy or antibody therapy within 3 weeks; Endocrine therapy and small molecule-targeted therapy within 2 weeks or 5 half-lives(whichever is shorter). Androgen-deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues (either GnRH agonists or GnRH antagonists) was allowed for men with prostate cancer.
- •Received any live vaccine within 4 weeks before the first dose of GenSci143 or intend to receive a live vaccine during the study.
- •History of allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.
- •Prior treatment with a topoisomerase inhibitor or an ADC that consists of a topoisomerase inhibitor.
- •History of severe hypersensitivity reactions to GenSci143 and/or excipients in the drug product, or other monoclonal antibodies.
- •Any illness (uncontrolled hypertension, serious diabetes mellitus, thyroid disorders, and psychiatric disorders, etc.) or other conditions that are not eligible for inclusion based on the investigator's judgment.
研究组 & 干预措施
GenSci143 for injection
Experimental
干预措施: GenSci143 for injection (Drug)
结局指标
主要结局
Part 1 and Part2:Incidence of adverse events Percentage of patients with adverse events by system organ class and preferred term.
时间窗: From time of informed consent to 30days post last dose of GenSci143
Part1:Dose limiting toxicities(DLTs),DLTs are assessed during the DLT observation period and defined as any toxicity in DLT definition in the Clinical Study Protocal
时间窗: Form time of first dose of GenSci143 to end of DLT observation period(approximately 21 days)
Part1: Maximum tolerated dose (MTD) and recommended dose for expansion (RDE) To determine the maximum tolerated dose (MTD) (if applicable) and recommended dose for expansion (RDE) of GenSci143.
时间窗: Form time of first dose of GenSci143 up to 12 months.
Part1: Part2: Composite response rate To evaluate the efficacy of GenSci143 as using RECIST v1.1 and/or PSA50 response (PCWG3) with PC
时间窗: Approximately 12 months.
Part1: Part2: Objective response rate(ORR) To evaluate the efficacy of GenSci143 as measured by ORR using RECIST v1.1 for participants with non-PC
时间窗: Approximately 12 months.
次要结局
- AUC of GenSci143 Calculate area under the curve of GenSci143.(Approximately 12 months.)
- AUC of total antibody Calculate area under the curve of total antibody.(Approximately 12 months)
研究者
研究点 (9)
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