Clinical Trial

A Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors

Study acronym: ABP1011T-03
Recruiting Phase 2
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Summary
This study is a multicenter, open-label, multi-cohort investigation exploring the efficacy and safety of ABP1011T tablets in participants with specific target solid tumors, providing a foundation for subsequent clinical research. Based on safety and efficacy data from the prior Phase I/IIa clinical trial (Protocol Number: ABP1011T-I/II-01), priority enrollment is given to participants with advanced solid tumors including small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma (excluding osteosarcoma). Cohort A (Cohort A1, Cohort A2, Cohort A3) comprises the small cell lung cancer cohort: Participants must have failed at least two prior systemic therapies. Cohort B enrolls participants with other advanced solid tumors (excluding osteosarcoma). ABP1011T tablets are administered as continuous therapy in clinical studies, with a 21-day treatment cycle. Participants take one tablet orally once daily on an empty stomach (with water, avoiding food for at least 1 hour before and after each dose).
Trial Details
NCT Number NCT07321574
Lead Sponsor Shanghai AB PharmaTech Ltd.
Collaborators: GCP ClinPlus Co., Ltd.
Conditions SCLC, Extensive Stage, Advanced Solid Tumors
Enrollment 110 participants
Start Date 2025-12-30
Primary Completion 2028-11-28 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-07