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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 is a Phase 1 study that has completed, run by Ascentage Pharma Group. The registered enrollment target is 50 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03080311
The ClinicalTrials.gov registry entry for NCT03080311 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascentage Pharma Group, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which APG-1252 is the first listed.
NCT03080311 reports 0 study locations.
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.
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