Clinical Trial

Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

Study acronym: PRESERVE-001

Active, Not Recruiting Phase 1/2

Record status

This record was last updated May 23, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 21 amendments

This ClinicalTrials.gov record has been amended 21 times since 2019-10-24; most recent amendment 2025-05-20.

Status change: Recruiting → Active, Not Recruiting 2025-05-20

Status change: Not Yet Recruiting → Recruiting 2020-07-22

Trial Details

NCT Number	NCT04140526
Lead Sponsor	OncoC4, Inc. Collaborators: National Cancer Institute (NCI)
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 +11 more
Enrollment	733 participants
Start Date	2020-09-16
Primary Completion	2026-06-30 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-23