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)

Trial ID #	NCT04140526
Phase	Ia/Ib
Drug Class	Immunotherapy: Checkpoint Inhibitors/CTLA-4
Drug Name	Gotistobart
Alternate Drug Names	BNT316, ONC-392
Drugs in Trial	Gotistobart
Eligible Participant	Platinum resistant or refractory ovarian cancer
Patients Enrolled	32
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, evaluated per RECIST
Efficacy	ORR: 21% (1CR, 5PR, n=28) DCR: 50% (1CR, 5PR, 8SD, n=28)
Clinically Significant Adverse Events	Serious AE: 1 hypotensive chock Grade 3-4 AE: overall (31%), colitis (13%)
Conclusion	Gotistobart as monotherapy shows encouraging anti-tumor activity in ovarian cancer
Reference	Hays J et al. SAFETY AND CLINICAL ACTIVITIES OF THE ACID PHSENSITIVE ANTI-CTLA-4 MAB ONC-392 IN OVARIAN CANCER PATIENTS. SITC (2022) abstract 594 https://www.clearityfoundation.org/wp-content/uploads/2023/02/SITC-2022-ONC392-abstract.pdf Hays J et al. Poster https://www.clearityfoundation.org/wp-content/uploads/2023/02/SITC-2022-ONC-392-poster.pdf