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NCT03386526 · ClinicalTrials.gov registry record · Phase 1
APG-1387 in Patients With Advanced Solid Tumors or Hematologic Malignancies
A Phase 1 study of Advanced Solid Tumors or Hematologic Malignancies, sponsored by Ascentage Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 3
- Study locations
NCT03386526: Completed Phase 1 study of Advanced Solid Tumors or Hematologic Malignancies, sponsored by Ascentage Pharma Group.
NCT03386526 is a Phase 1 study of Advanced Solid Tumors or Hematologic Malignancies that has completed, run by Ascentage Pharma Group. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03386526, a Phase 1 study of Advanced Solid Tumors or Hematologic Malignancies, has completed, sponsored by Ascentage Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 3
- Study locations
Study Summary
APG-1387 is a potent, bivalent small-molecule Inhibitor of Apoptosis Protein (IAP) antagonist. APG-1387 has shown strong dose- and schedule-dependent antitumor activities in multiple human cancer xenograft models, APG-1387 also demonstrates its synergistic effect in combination with immune checkpoint inhibitor anti-PD-1 antibody, and such a combinatory effect was further enhanced by chemotherapeutic agent. A total of 35 patients with advanced solid tumors or lymphomas have been treated with APG-1387 in two Phase I dose-escalation studies in Australia and in China. Ten dose levels have been tested ranging from 0.3 mg to 45 mg in these two studies. Based on the preliminary results, APG-1387 is well-tolerated at the dose levels evaluated to date. APG-1387 is intended for the treatment of patients with advanced solid tumors and hematologic malignancies. After establishing the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several Ib /II studies will be implemented accordingly to further access the antitumor effects of APG-1387 in combination with either pembrolizumab or the chemotherapeutic agents.
Primary Outcome
Patients with APG-1387 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03
Conditions Studied
Interventions
- DRUG APG-1387 for Injection
Study Locations (3)
Michigan
- University of Michigan - Ann Arbor
- START Midwest - Grand Rapids
Texas
- The START Center for Cancer Care - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2017-11-21 |
| Est. Completion | 2022-11-30 |
| Phase | Phase 1 |
What the finished NCT03386526 record still lists
NCT03386526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Advanced Solid Tumors or Hematologic Malignancies appearing as the primary indexed condition, and to 1 intervention - of which APG-1387 for Injection is the first listed.
NCT03386526 reports a single indexed study location in Michigan, Texas.
Frequently Asked Questions
What is clinical trial NCT03386526 about?
NCT03386526 is a clinical study titled "APG-1387 in Patients With Advanced Solid Tumors or Hematologic Malignancies". APG-1387 is a potent, bivalent small-molecule Inhibitor of Apoptosis Protein (IAP) antagonist. APG-1387 has shown strong dose- and schedule-dependent antitumor activities in multiple human cancer xenograft models, APG-1387 also demonstrates its synergistic effect in combination with immune checkpoin...
What is the current status of trial NCT03386526?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2017-11-21. Estimated completion is 2022-11-30.
What conditions does trial NCT03386526 study?
This clinical trial studies the following conditions: Advanced Solid Tumors or Hematologic Malignancies.
What interventions are being tested in trial NCT03386526?
The interventions under investigation include: APG-1387 for Injection (DRUG).
Who is sponsoring clinical trial NCT03386526?
This trial is sponsored by Ascentage Pharma Group, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03386526 being conducted?
This trial has 3 study locations across Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03386526's enrollment target sits among peer trials
90 628th of 2000 higher than 1,352 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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