GenSci143 for injection: GenSci143 for injection, administered Q3W, with a dosage ranging from 0.5mg/kg to 4.5mg/kg.
Study summary
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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:
1. 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.
2. 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 v1.1. 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:
1. 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).
2. 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.
3. Renal function: creatinine clearance (CLcr) ≥ 50 mL/min as calculated using the Cockcroft-Gault formula.
4. 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 ≤1.
* Women of childbearing potential (WOCBP) must have a serum pregnancy test negative within 7 days before the first dose of GenSci143. 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 GenSci143. 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.
Exclusion Criteria:
* 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 GenSci143.
* History of other known malignancies within the past 3 years.
* Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose of GenSci143.
* 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 GenSci143.
* 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 GenSci143.
* 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.
Primary outcome measure(s)
Part 1 and Part2:Incidence of adverse events Percentage of patients with adverse events by system organ class and preferred term. — 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 — 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. — 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 — 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 — Approximately 12 months.
Trial sites (9)
Facility
City
Region
Status
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Recruiting
Hubei Cancer Hospital
Wuhan
Hubei
Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Not Yet Recruiting
Nanjing Drum Tower Hospital
Nanjing
Jiangsu
Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Not Yet Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai
Shanghai Municipality
Not Yet Recruiting
The First Hospital of Shanxi Medical University
Taiyuan
Shanxi
Not Yet Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Not Yet Recruiting
More Changchun GeneScience Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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