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
StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 30, 2026 → Dec 31, 2026
See other at-risk trials from OncoC4, Inc.

Record History

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  1. Primary completion pushed from Jun 30, 2026 to Dec 31, 2026v23
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 37 of 37 sites
    v22
  3. Publications: 6 to 10v21
  4. Primary completion date: Jun 30, 2024 to Jun 30, 2026v20 Show 6 more changesShow less
    • Enrollment target: 914 to 733
    • Study sites: 39 to 37
    • Study completion date: Dec 31, 2024 to Dec 31, 2027
    • Interventions: ONC-392 (Drug), Pembrolizumab (Drug) to Docetaxel (Drug), ONC-392 (Drug), Pembrolizumab (Drug)
    • Study description expanded, about 16 words
    • Study arms: 2 to 3
  5. Primary completion date: Dec 31, 2023 to Jun 30, 2024v19
Show 17 earlier versionsHide 17 earlier versions
  1. Enrollment target: 468 to 914
    • Study sites: 38 to 39
    • Study description expanded, about 15 words
    v18
  2. Site details revised at 5 of 38 sitesv17
  3. Study sites: 39 to 38v16
  4. Site details revised at 1 of 39 sitesv15
  5. Study sites: 35 to 39v14
  6. Phase: Phase 1 to Phase 1/2v13 Show 6 more changesShow less
    • Enrollment target: 413 to 468
    • Study sites: 31 to 35
    • Interventions: ONC-392 (Drug), Osimertinib (Drug), Pembrolizumab (Drug) to ONC-392 (Drug), Pembrolizumab (Drug)
    • Eligibility criteria shortened, about 96 words
    • Study description shortened, about 95 words
    • Study arms: 3 to 2
  7. Study sites revised (31)v12
  8. Primary completion date: Dec 31, 2022 to Dec 31, 2023v11 Show 5 more changesShow less
    • Enrollment target: 300 to 413
    • Study sites: 9 to 31
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    • Eligibility criteria shortened, about 114 words
    • Study description expanded, about 182 words
  9. Site details revised at 2 of 9 sitesv10
  10. Enrollment target: 91 to 300v9 Show 7 more changesShow less
    • Study sites: 4 to 9
    • Primary completion date: Jul 31, 2022 to Dec 31, 2022
    • Study completion date: Jul 31, 2023 to Dec 31, 2023
    • Interventions: ONC-392 (Drug), Pembrolizumab (Drug) to ONC-392 (Drug), Osimertinib (Drug), Pembrolizumab (Drug)
    • Study description expanded, about 229 words
    • Study arms: 2 to 3
    • Eligibility criteria expanded, about 4 words
  11. Start date: Jul 16, 2020 to Sep 16, 2020v8 Show 4 more changesShow less
    • Study sites: 1 to 4
    • Primary completion date: Jul 2022 to Jul 31, 2022
    • Study completion date: Jul 2023 to Jul 31, 2023
    • Eligibility criteria shortened, about 223 words
  12. Re-verified, no change to tracked fieldsv7
  13. Lead sponsor: Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) to OncoC4, Inc.v6
  14. Re-verified, no change to tracked fieldsv5
  15. Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Primary completion date: Feb 2022 to Jul 2022
    • Study completion date: Feb 2023 to Jul 2023
    • Start date changed from estimate of May 2020 to Jul 16, 2020
    • Study site revised
    • Collaborators expanded, about 4 words
  16. Start date: Feb 2020 to May 2020v3
  17. Phase: Phase 1/2 to Phase 1
    • Study description expanded, about 6 words
    • Publications: 5 to 6
    • Eligibility criteria expanded, about 5 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
OncoC4, Inc.
9 trials monitored
See 2 trials at risk
Breast Cancer
5,486 trials monitored
See 311 trials at risk
Lung Cancer
4,822 trials monitored
See 267 trials at risk
Colorectal Cancer
3,420 trials monitored
See 162 trials at risk
and 13 more diseases
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.
Trial Details
NCT Number NCT04140526
Lead Sponsor OncoC4, Inc.
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 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
Related terms Breast Neoplasms, Carcinoma, Adenoid Cystic, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Colorectal Neoplasms, Esophageal Neoplasms, Melanoma, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Salivary Gland Neoplasms, Sarcoma, Small Cell Lung Carcinoma, Stomach Neoplasms, Uterine Cervical Neoplasms
Enrollment 733 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov