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 ONC-392, BNT316
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

ONC-392 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

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