NCT04284488

Dose-escalation Study of APG-1387 and Toripalimab in Solid Tumors

A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of APG-1387 in Combination With Toripalimab in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An ascending dose study in patients with solid tumors to evaluate the safety, tolerability, pharmacodynamics and efficacy of APG-1387 in combination with toripalimab. A phase II study of 3 cohorts will be included.

Detailed description

This study will be conducted in two phases. In phase Ib, the safety and efficacy of different dose levels of APG-1387 in combination with 240 mg toripalimab will be explored to determine the recommended Phase 2 dose (RP2D) of APG-1387 in combination therapy, both administered as a 30-minute intravenous (IV) infusion. The following proposed doses of APG-1387 are to be evaluated: 20,30, or 45mg . The Phase II portion, will compromise 3 cohorts of 15-25 patients. The 3 cohorts will include the following: * Colorectal cancer * Nasopharyngeal carcinoma * Non-small cell lung cancer with PD-1 antibody refractory or relapse.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	APG-1387 for Injection	APG-1387 IV on Days 1 and 8 of each 21-Day Cycle. The following doses of APG-1387 to be studied: 20, 30, and 45mg. In the phase II, the assigned recommended phase two dose will be administered in all cohorts.
DRUG	Toripalimab	240 mg toripalimab IV on Day 1 of each 21-Day Cycle

Timeline

• Start date: 2020-04-10
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2020-02-25
• Last updated: 2026-01-08

Locations

3 sites across 1 country: China