GenSci143 in Participants With Advanced Solid Tumors

NCT07252414 | Recruiting Phase 1

• 1 other identifier: GenSci143-101
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 9

Brief Summary

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• 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.

Secondary Outcomes (2)

• 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

Other Outcomes (36)

• AUC of unconjugated payload. Calculate area under the curve of unconjugated payload

  Approximately 12 months

• Cmax of GenSci143 Calculate maximum concentration of GenSci143.

  Approximately 12 months

• Cmax of total antibody Calculate maximum concentration of total antibody

  Approximately 12 months

Study Arms (1)

GenSci143 for injection

EXPERIMENTAL

Drug: GenSci143 for injection

Interventions

GenSci143 for injection DRUG

GenSci143 for injection, administered Q3W, with a dosage ranging from 0.5mg/kg to 4.5mg/kg.

GenSci143 for injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 v1.1. 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (9)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 451191, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310024, China

NOT YET RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Dingwei Ye

CONTACT

+86 13701663571; dwyeli@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-11

Locations

CN (9)