{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"PRESERVE-001","nct_id":"NCT04140526","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=preserve-001-nct04140526. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"PRESERVE-001","arms":[{"description":"The Part A study will test ONC-392 intravenous (IV) infusion up to five predefined dose levels from 0.1 mg/kg to 10 mg/kg ONC-392 as monotherapy every 21 days (Q3W). The Part A study will determine the maximal tolerable dose (MTD) and the recommended Phase 2 dose in monotherapy (RP2D-M).\n\nIn Part C, Arms A-C, I-N monotherapy expansion cohorts will further assess the safety and efficacy of ONC-392 in different dose levels as monotherapy in pancreatic cancer, triple negative breast cancer, non small cell lung cancer with driver mutations, PD-1 resistant non small cell lung cancer, PD-1 resistant melanoma, head and neck cancer, ovarian cancer, renal cell carcinoma and other solid tumors.\n\nPart D is a Phase II study on recurrent and/or metastatic adenoid cystic carcinoma.","label":"ONC-392 Treatment as single agent","type":"EXPERIMENTAL"},{"description":"The Part B1 study will test ONC-392 intravenous (IV) infusion, Q3W, in combination with fixed dose of pembrolizumab. The dose for pembrolizumab will be fixed at 200mg/cycle dosed every 21 days (Q3W).\n\nThe Part B1 will start at one level below RP2D-M dose for ONC-392 and 200mg of pembrolizumab. When 2 DLTs occur before 6 patients are enrolled, the ONC-392 dose will be decreased to the next dose level until ≤ 1/6 patients treated at that dose develops a DLT. This dose level will be designated RP2D-C.\n\nIn Part C, the expansion cohorts Arm D to G will assess the safety and efficacy of ONC-392 in different dose levels and Pembrolizumab combination therapy in non small cell lung cancer, and metastatic melanoma.","label":"ONC-392 in combination with pembrolizumab","type":"EXPERIMENTAL"},{"description":"Part E Arm O will test ONC-392 in combination with docetaxel, IV infusion, Q3W, in PD-1 resistant NSCLC patients.","label":"ONC-392 and docetaxel","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2027-12-31","type":"ESTIMATED"},"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"],"enrollment":{"count":733,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"ONC-392","otherNames":["A humanized anti-CTLA4 IgG1 monoclonal antibody made by OncoC4, Inc."],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["Keytruda","MK3475"],"type":"DRUG"},{"name":"Docetaxel","otherNames":["Taxotere, Docefrez"],"type":"DRUG"}],"last_update":"2026-09-14","lead_sponsor":"OncoC4, Inc.","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)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2026-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Dose limiting toxicity (DLT) in monotherapy","timeFrame":"21 days"},{"measure":"Maximal tolerable dose (MTD) in monotherapy","timeFrame":"21 days"},{"measure":"Recommended Phase II Dose (RP2D)","timeFrame":"21 days"},{"measure":"Rate of treatment related adverse events (TRAE) according to CTCAE v5.0","timeFrame":"One year"}],"references":[{"citation":"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.","pmid":"31267017","type":"BACKGROUND"},{"citation":"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.","pmid":"29472691","type":"BACKGROUND"},{"citation":"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.","pmid":"29463898","type":"BACKGROUND"},{"citation":"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.","pmid":"15486062","type":"BACKGROUND"},{"citation":"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.","pmid":"16037385","type":"BACKGROUND"},{"citation":"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.","pmid":"31836191","type":"BACKGROUND"},{"citation":"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","pmid":null,"type":"RESULT"},{"citation":"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","pmid":null,"type":"RESULT"},{"citation":"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","pmid":null,"type":"RESULT"},{"citation":"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","pmid":null,"type":"RESULT"}],"start_date":{"date":"2020-09-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC","url":"https://clinicaltrials.gov/study/NCT04140526"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/preserve-001-nct04140526"}