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NCT04140526 · ClinicalTrials.gov registry record · Phase 1
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by OncoC4.
- Active
- Registry status
- Phase 1
- Development phase
- 733
- Enrollment target
- 20
- Study locations
NCT04140526: Active Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by OncoC4.
NCT04140526 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that is active but no longer recruiting, run by OncoC4. The registered enrollment target is 733 participants, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04140526, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by OncoC4.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 733 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.
Primary Outcome
The number of subjects who have dose limiting toxicity during the first cycle of study drug, ONC-392, administration.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Docetaxel
- DRUG ONC-392
Study Locations (20)
Florida
- Florida Cancer Specialists - Atlantis
- University of Florida Health Cancer Center - Gainesville
- Ocala Oncology Florida Cancer Affiliates - Ocala
- AdventHealth Cancer Institute - Orlando
- Memorial Cancer Institute - Pembroke Pines
California
- University of California at Davis - Davis
- The Oncology Institute of Hope and Innovation - Downey
- City of Hope Cancer Center - Duarte
Maryland
- Greater Baltimore Medical Center - Baltimore
- The Center for Cancer and Blood Disorders - Bethesda
Massachusetts
- Dana Farber Cancer Institute - Boston
- Massachusetts General Hospital - Boston
Arkansas
- Highlands Oncology Group - Springdale
Colorado
- University of Colorado Hospital - Aurora
Connecticut
- Nuvance Health - Norwalk
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 733 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04140526 still lists
NCT04140526 is an interventional study that assigns participants to a tested intervention. The registered 733 participants enrollment target is mid-sized for trials with a published cap, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (13% higher).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04140526 names 20 study sites across 12 states, led by Florida, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT04140526 about?
NCT04140526 is a clinical study titled "Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC". This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell l...
What is the current status of trial NCT04140526?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 733 participants. The study started on 2020-09-16. Estimated completion is 2027-12-31.
What conditions does trial NCT04140526 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Ovarian Cancer, Advanced Solid Tumor, Metastatic Melanoma, Small-cell Lung Cancer.
What interventions are being tested in trial NCT04140526?
The interventions under investigation include: Pembrolizumab (DRUG), Docetaxel (DRUG), ONC-392 (DRUG).
Who is sponsoring clinical trial NCT04140526?
This trial is sponsored by OncoC4, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04140526 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04140526's enrollment target sits among peer trials
733 41st of 454 higher than 414 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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