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Clinical trial · no report yet · Phase 1/Phase 2
PRESERVE-001
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
- NCT04140526 ↗
- Active, not recruiting
- OncoC4, Inc.
- Focused size, estimated: 1–150 verified statements
We haven't built an HCP commentary report on PRESERVE-001 yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on PRESERVE-001 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Indexed so far | |
|---|---|
| 4 posts on X |
The trial
ClinicalTrials.gov- 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)
- Phase
- Phase 1/Phase 2
- Status
- Active, not recruiting
- 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
- Interventions
- ONC-392; Pembrolizumab; Docetaxel
- Arms
- ONC-392 Treatment as single agent · Experimental
- ONC-392 in combination with pembrolizumab · Experimental
- ONC-392 and docetaxel · Experimental
- Enrollment
- 733 (estimated)
- Primary outcomes
- Dose limiting toxicity (DLT) in monotherapy
- Maximal tolerable dose (MTD) in monotherapy
- Recommended Phase II Dose (RP2D)
- Rate of treatment related adverse events (TRAE) according to CTCAE v5.0
- Sponsor
- OncoC4, Inc. with National Cancer Institute (NCI)
- Start
- Sep 16, 2020
- Primary completion
- Dec 31, 2026 (estimated)
- Results posted
- No
- Registry record
- NCT04140526 · updated Sep 14, 2026
Publications
linked from the registry- Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2. PubMed 31267017
- Du X, Tang F, Liu M, Su J, Zhang Y, Wu W, Devenport M, Lazarski CA, Zhang P, Wang X, Ye P, Wang C, Hwang E, Zhu T, Xu T, Zheng P, Liu Y. A reappraisal of CTLA-4 checkpoint blockade in cancer immunotherapy. Cell Res. 2018 Apr;28(4):416-432. doi: 10.1038/s41422-018-0011-0. Epub 2018 Feb 22. PubMed 29472691
- Du X, Liu M, Su J, Zhang P, Tang F, Ye P, Devenport M, Wang X, Zhang Y, Liu Y, Zheng P. Uncoupling therapeutic from immunotherapy-related adverse effects for safer and effective anti-CTLA-4 antibodies in CTLA4 humanized mice. Cell Res. 2018 Apr;28(4):433-447. doi: 10.1038/s41422-018-0012-z. Epub 2018 Feb 20. PubMed 29463898
- May KF Jr, Roychowdhury S, Bhatt D, Kocak E, Bai XF, Liu JQ, Ferketich AK, Martin EW Jr, Caligiuri MA, Zheng P, Liu Y. Anti-human CTLA-4 monoclonal antibody promotes T-cell expansion and immunity in a hu-PBL-SCID model: a new method for preclinical screening of costimulatory monoclonal antibodies. Blood. 2005 Feb 1;105(3):1114-20. doi: 10.1182/blood-2004-07-2561. Epub 2004 Oct 14. PubMed 15486062
- Lute KD, May KF Jr, Lu P, Zhang H, Kocak E, Mosinger B, Wolford C, Phillips G, Caligiuri MA, Zheng P, Liu Y. Human CTLA4 knock-in mice unravel the quantitative link between tumor immunity and autoimmunity induced by anti-CTLA-4 antibodies. Blood. 2005 Nov 1;106(9):3127-33. doi: 10.1182/blood-2005-06-2298. Epub 2005 Jul 21. PubMed 16037385
- Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10. PubMed 31836191
- Li T, Tang M, Kelly, K, Chen HA, Joo S, Khan I, Do N, Touomou R, Chen D, Liu Y, Zheng P. 949 First-in-human study of the first acid pH-sensitive and recycling CTLA-4 antibody that preserves the immune tolerance checkpoint to avoid immunotherapy-related adverse events in cancer patients. Journal for ImmunoTherapy of Cancer, 2021. 9(Suppl 2): p. A998-A998. doi: 10.1136/jitc-2021-SITC2021.949
- Hu-Lieskovan S, He K, Tang M, Chen D, Liu Y, Zheng P, Li T. 594 Dose escalation of next generation anti-CTLA-4 antibody ONC-392 in combination with fixed dose of pembrolizumab in patients with advanced solid tumors. Journal for ImmunoTherapy of Cancer, 2022. 10(Suppl 2): p. A622-A622. doi: 10.1136/jitc-2022-SITC2022.0594
- He K, Carbone DP, McKean M, Balaraman R, Shah S, Arrowsmith E, Peguero JA, Joshi R, He AR, Milillo A, Hamm JT, Goldstein MG, Li Z, Liu Y, Zheng P, Li T. Safety and clinical activity of target-preserving anti-CTLA-4 antibody ONC-392 as monotherapy in NSCLC patients who progressed on PD(L)1-targeted immunotherapy. Journal of Clinical Oncology, 2023. 41(16_suppl): p. 9024-9024. doi: 10.1200/JCO.2023.41.16_suppl.9024
- He K, McKean M, Balaraman R, Shah S, Arrowsmith E, Peguero JA, Hamm JT, He AR, Spira AI, Milillo-Naraine A, Joshi R, Goldstein MG, Carbone DP, Tang M, Hu-Lieskovan S, Li Z, Chen D, Chou HY, Yang J, Liu Y, Zheng P, Li T. 599 Single-agent safety and activities of target-preserving anti-CTLA-4 antibody gotistobart (ONC-392/BNT316) in PD-(L)1 resistant metastatic NSCLC and population PK analysis in patients with solid tumors. Journal for ImmunoTherapy of Cancer, 2023. 11(Suppl 1): p. A682-A682. doi: 10.1136/jitc-2023-SITC2023.0599