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NCT03080311 · ClinicalTrials.gov registry record · Phase 1
A Study of APG-1252 in Patients With SCLC or Other Solid Tumors
A Phase 1 study, sponsored by Ascentage Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT03080311: Completed Phase 1 study, sponsored by Ascentage Pharma Group.
NCT03080311 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
NCT03080311, 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-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w. The preclinical studies have shown that APG-1252 alone achieves complete and persistent tumor regression in multiple tumor xenograft models with a twice weekly or weekly dose-schedule, including SCLC, colon, breast and acute lymphocytic leukemia (ALL) cancer xenografts; achieves strong synergy with the chemotherapeutic agents, indicating that APG-1252 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-1252 is intended for the treatment of patients with SCLC or other solid tumors. This is a multi-center, open-label, dose escalation Phase I study to determine the MTD and DLTs of intravenously administered APG-1252. After dose escalation to 240mg twice weekly, 2 dose cohorts two different dosing schedules including weekly and twice weekly will be assessed to evaluate for safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor efficacy. Treatment with APG-1252 will be administered to 30-60 patients at approximately 2 investigational sites in US.
Primary Outcome
Number of participants with APG-1252 treatment-related adverse events as assessed by NCI CTCAE v4.03
Interventions
- DRUG APG-1252
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-02-12 |
| Est. Completion | 2020-07-17 |
| Phase | Phase 1 |
What the finished NCT03080311 record still lists
NCT03080311 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-1252 is the first listed.
NCT03080311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03080311 about?
NCT03080311 is a clinical study titled "A Study of APG-1252 in Patients With SCLC or Other Solid Tumors". APG-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w. The preclinical studies have shown that APG-1252 alone achieves complete and persistent tumor regression in multiple tumor xenograft models with a tw...
What is the current status of trial NCT03080311?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2017-02-12. Estimated completion is 2020-07-17.
What interventions are being tested in trial NCT03080311?
The interventions under investigation include: APG-1252 (DRUG).
Who is sponsoring clinical trial NCT03080311?
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 NCT03080311'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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