NCT07321574

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

An Open-Label, Multi-Cohort Phase IIb Clinical Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Shanghai AB PharmaTech Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• SCLC, Extensive Stage
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ABP1011T	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).

Timeline

• Start date: 2025-12-30
• Primary completion: 2028-11-28
• Completion: 2028-12-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

8 sites across 1 country: China

Regulatory

• FDA-regulated drug study