Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
Public ClinicalTrials.gov record NCT04140526. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04140526
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 733 participants
Conditions and interventions
Conditions
- Non Small Cell Lung Cancer
- Advanced Solid Tumor
- Metastatic Melanoma
- Metastatic Head and Neck Carcinoma
- Metastatic Renal Cell Carcinoma
- Metastatic Colorectal Cancer
- Sarcomas
- Metastatic Prostate Cancer
- Ovarian Cancer
- Small Cell Lung Cancer
- Metastatic Breast Cancer
- Pancreas Cancer
- Gastric Cancer
- Esophageal Cancer
- Gastroesophageal Junction Adenocarcinoma
- Cervical Cancer
- Adenoid Cystic Carcinoma
- Salivary Gland Cancer
- Urothelial Carcinoma
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 16, 2020 (Actual)
- Primary completion
- Dec 31, 2026 (Estimated)
- Completion
- Dec 31, 2027 (Estimated)
- Last update posted
- Sep 14, 2026
2020 – 2027
United States locations
- U.S. sites
- 33
- U.S. states
- 21
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | — |
| University of California at Davis | Davis | California | 95817 | — |
| The Oncology Institute of Hope and Innovation | Downey | California | 90241 | — |
| City of Hope Cancer Center | Duarte | California | 91010 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Nuvance Health | Norwalk | Connecticut | 06856 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Florida Cancer Specialists | Atlantis | Florida | 33462 | — |
| University of Florida Health Cancer Center | Gainesville | Florida | 32610 | — |
| Ocala Oncology Florida Cancer Affiliates | Ocala | Florida | 34474 | — |
| AdventHealth Cancer Institute | Orlando | Florida | 32804 | — |
| Memorial Cancer Institute | Pembroke Pines | Florida | 33028 | — |
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Norton Health | Lexington | Kentucky | 40202 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| The Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | — |
| Atlantic Healthcare System | Morristown | New Jersey | 07960 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | — |
| The Ohio State University James Cancer Center | Columbus | Ohio | 43210 | — |
| Zangmeister Cancer Center | Columbus | Ohio | 43219 | — |
| Pennsylvania Cancer Specialists & Research Institute (Formerly Gettysburg Cancer Center) | Gettysburg | Pennsylvania | 17325 | — |
| Prisma Health | Greenville | South Carolina | 29605 | — |
| Tennessee Oncology Chattanooga Memorial Plaza | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology - Nashville | Nashville | Tennessee | 37203 | — |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | — |
| Oncology Consultants | Houston | Texas | 77030 | — |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| NEXT/Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| University of Washington / Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04140526, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04140526 live on ClinicalTrials.gov.