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

NCT04284488 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

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

Sponsors & Collaborators

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Yifan Zhai, M.D., Ph.D. · Ascentage Pharma Group Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-10
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04284488 on ClinicalTrials.gov