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NCT02935907 · ClinicalTrials.gov registry record · Phase 1
APG-115 in Patients With Advanced Solid Tumors or Lymphomas
A Phase 1 study, sponsored by Ascentage Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT02935907: Completed Phase 1 study, sponsored by Ascentage Pharma Group.
NCT02935907 is a Phase 1 study that has completed, run by Ascentage Pharma Group. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02935907, a Phase 1 study, has completed, sponsored by Ascentage Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
APG-115 is a novel, orally active small-molecule mouse double minute 2 homolog (MDM2) inhibitor. Mechanistically, APG-115 increases p53 and p21 overexpression, activates p53 - mediated apoptosis in tumor cells retaining wild-type p53. APG-115 has shown strong dose- and schedule-dependent antitumor activities in multiple human cancer xenograft and a patient derived xenograft (PDX) models. The preclinical data generated from APG-115 suggest that it may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-115 is intended for the treatment of patients with advanced solid tumors and lymphomas. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will be implemented accordingly.
Primary Outcome
Patients with APG-115 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.0
Interventions
- DRUG APG-115
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-10 |
| Est. Completion | 2019-06-28 |
| Phase | Phase 1 |
What the finished NCT02935907 record still lists
NCT02935907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which APG-115 is the first listed.
NCT02935907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02935907 about?
NCT02935907 is a clinical study titled "APG-115 in Patients With Advanced Solid Tumors or Lymphomas". APG-115 is a novel, orally active small-molecule mouse double minute 2 homolog (MDM2) inhibitor. Mechanistically, APG-115 increases p53 and p21 overexpression, activates p53 - mediated apoptosis in tumor cells retaining wild-type p53. APG-115 has shown strong dose- and schedule-dependent antitumor a...
What is the current status of trial NCT02935907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2016-10. Estimated completion is 2019-06-28.
What interventions are being tested in trial NCT02935907?
The interventions under investigation include: APG-115 (DRUG).
Who is sponsoring clinical trial NCT02935907?
This trial is sponsored by Ascentage Pharma Group, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02935907's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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