ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer

Summary

This is a study to test the safety and efficacy with the combination of a next generation anti-CTLA-4 antibody, ONC-392, and anti-PD-1 antibody, pembrolizumab, in platinum resistant ovarian cancer patients.

Timeline

Start

2022-12-22

Primary completion

2026-08-30

Completion

2026-08-30

Publications

• Background 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.
• Background 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.
• Results Barlin JN, Lim PC, Thomes Pepin J, Hopp EE, Cloven NG, Lee C, Eshed HD, Black D, Cottrill HM, Hand L, O'Malley DM, Chuang LT, Willmott L, Chisamore M, Shpyro S, Durbin J, Zheng P, Liu Y, Monk BJ. LBA32 A randomized, phase II, dose optimization of gotistobart, a pH-sensitive anti-CTLA-4, in combination with standard dose pembrolizumab in platinum-resistant recurrent ovarian cancer: Safety, efficacy and dose optimization (PRESERVE-004/GOG-3081). Annals of Oncology, 2024. 35: p. S1224-S1225. doi: 10.1016/j.annonc.2024.08.2271
• Results Barlin JN, Lim PC, Thomes Pepin J, Hopp EE, Cloven NG, Eshed HD, Black D, Cottrill HM, Hand L, O'Malley DM, Chuang LT, Chisamore M, Durbin J, Zheng P, Liu Y, Shpyro S, Monk BJ.LB010/#1590 A phase 2 randomized dose optimization trial of gotistobart, a PH-sensitive anti-CTLA-4, in combination with pembrolizumab in platinum-resistant ovarian cancer (PROC, preserve-004/GOG-3081; NCT05446298). International Journal of Gynecological Cancer, 2024. 34: p. A6-A8. doi: 10.1136/ijgc-2024-IGCS.7

Drugs

Indications