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Recruiting Phase 1 NCT07252414

GenSci143 in Participants With Advanced Solid Tumors

Trial Parameters

Condition Advanced Solid Tumors
Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 180
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-20
Completion 2028-10-30
Interventions
GenSci143 for injection

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

Eligibility Criteria

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 availab

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