Study Summary
This trial is testing a new drug, ONC-392, as a possible treatment for advanced or metastatic solid tumors and non-small cell lung cancers. The trial will test different doses of the drug to see what is safe and what works best. The trial will also test ONC-392 in combination with another drug, pembrolizumab.
Eligible Conditions
- Stomach Cancer
- Sarcoma
- Hormone-Refractory Prostate Cancer
- Pancreatic Cancer
- Gastroesophageal Junction Adenocarcinoma
- Salivary Gland Cancer
- Metastatic Breast Cancer
- Adenoid Cystic Carcinoma
- Advanced Solid Tumors
- Esophageal Cancer
- Cutaneous Neuroendocrine Carcinoma
- Non-Small Cell Lung Cancer
- Metastatic Colorectal Cancer
- Small Cell Lung Cancer
- Ovarian Cancer
- Cervical Cancer
- Kidney Cancer
- Bladder Cancer
- Metastatic Melanoma
- Head and Neck Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 5 Secondary · Reporting Duration: 1 year
1 year
Objective Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)
12 weeks
The serum half life of the study drug, ONC-392, in combination therapy with Pembrolizumab.
The serum half life of the study drug, ONC-392, in monotherapy.
21 days
Dose limiting toxicity (DLT) in monotherapy
Maximal tolerable dose (MTD) in monotherapy
Recommended Phase II Dose (RP2D)
One year
Rate of treatment related adverse events (TRAE) according to CTCAE v5.0
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
ONC-392 in combination with Osimertinib
1 of 3
ONC-392 Treatment as single agent
1 of 3
ONC-392 in combination with pembrolizumab
1 of 3
Experimental Treatment
468 Total Participants · 3 Treatment Groups
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1 & 2
ONC-392 in combination with OsimertinibExperimental Group · 2 Interventions: Osimertinib, ONC-392 · Intervention Types: Drug, Drug
ONC-392 Treatment as single agent
Drug
Experimental Group · 1 Intervention: ONC-392 · Intervention Types: DrugONC-392 in combination with pembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, ONC-392 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved
Pembrolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
OncoC4, Inc.Lead Sponsor
3 Previous Clinical Trials
748 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,099 Previous Clinical Trials
41,145,319 Total Patients Enrolled
449 Trials studying Sarcoma
236,017 Patients Enrolled for Sarcoma
Tianhong Li, MDPrincipal InvestigatorUniversity of California, Davis
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have histological or cytological diagnosis of NSCLC or any other type of carcinoma or sarcomas, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy.
Patients with advanced/metastatic solid tumors of any histology are eligible for this study.
You have cancer of the pancreas, triple negative breast cancer, non small cell lung cancer, melanoma, head and neck cancer, ovarian cancer, and other solid tumors.
Patients with recurrent or metastatic adenoid cystic carcinoma with disease progression within 12 months are eligible.
You are 18 or older and a male or female.
Patient must have a performance status of 0 or 1 on the ECOG Performance Scale.
References
- Du, Xuexiang, Fei Tang, Mingyue Liu, Juanjuan Su, Yan Zhang, Wei Wu, Martin Devenport, et al.. 2018. “A Reappraisal of CTLA-4 Checkpoint Blockade in Cancer Immunotherapy”. Cell Research. Springer Science and Business Media LLC. doi:10.1038/s41422-018-0011-0.
- May, Kenneth F., Jr, Sameek Roychowdhury, Darshna Bhatt, Ergun Kocak, Xue-Feng Bai, Jin-Qing Liu, Amy K. Ferketich, et al.. 2005. “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. American Society of Hematology. doi:10.1182/blood-2004-07-2561.
- Zhang, Yan, Xuexiang Du, Mingyue Liu, Fei Tang, Peng Zhang, Chunxia Ai, James K. Fields, et al.. 2019. “Hijacking Antibody-induced CTLA-4 Lysosomal Degradation for Safer and More Effective Cancer Immunotherapy”. Cell Research. Springer Science and Business Media LLC. doi:10.1038/s41422-019-0184-1.
- Du, Xuexiang, Mingyue Liu, Juanjuan Su, Peng Zhang, Fei Tang, Peiying Ye, Martin Devenport, et al.. 2018. “Uncoupling Therapeutic from Immunotherapy-related Adverse Effects for Safer and Effective Anti-ctla-4 Antibodies in CTLA4 Humanized Mice”. Cell Research. Springer Science and Business Media LLC. doi:10.1038/s41422-018-0012-z.
- Lute, Kenneth D., Kenneth F. May Jr, Ping Lu, Huiming Zhang, Ergun Kocak, Bedrick Mosinger, Christopher Wolford, et al.. 2005. “Human CTLA4 Knock-in Mice Unravel the Quantitative Link Between Tumor Immunity and Autoimmunity Induced by Anti–ctla-4 Antibodies”. Blood. American Society of Hematology. doi:10.1182/blood-2005-06-2298.
- Liu, Yang, and Pan Zheng. 2020. “Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy”. Trends in Pharmacological Sciences. Elsevier BV. doi:10.1016/j.tips.2019.11.003.
- 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.
- 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.
- 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.
- 2020. "Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04140526.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments