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

Advanced Solid Tumor Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04284488
Study type Interventional
Source Ascentage Pharma Group Inc.
Contact Ruihua Xu, Professor
Phone +86-20-87343468
Email xurh@sysucc.org.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date April 10, 2020
Completion date April 30, 2024
View Details
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