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Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
NCT04140526 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04140526
The ClinicalTrials.gov registry entry for NCT04140526 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 733 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OncoC4, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04140526 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Ovarian Cancer, Advanced Solid Tumor, Non Small Cell Lung Cancer, Metastatic Melanoma, Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04140526?
The interventions under investigation include: Pembrolizumab (DRUG), Docetaxel (DRUG), ONC-392 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04140526?
This trial is sponsored by OncoC4, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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