| Trial ID # | NCT03860272 |
| Phase | I |
| Drug Class | Immunotherapy: Checkpoint Inhibitors/CTLA-4 |
| Drug Name | Botensilimab |
| Alternate Drug Names | AGEN1181, anti-CTLA-4 monoclonal antibody AGEN1181 |
| Drugs in Trial | Balstilimab, Botensilimab |
| Eligible Participant | Platinum resistant ovarian cancer |
| Patients Enrolled | 24; median 4 prior therapies (1-8); 19 HGS, 1 carcinosarcoma, 2 CCOC, 2 mixed CCOC/endometrioid |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, evaluated per RECIST |
| Efficacy | Bot: |
| Clinically Significant Adverse Events | Serious AE: |
| Conclusion | Botenlisimab alone or in combination with balstilimab demonstrates clinical activity in platinum resistant OC. Activity is seen both in patients with the low and high affinity FcγRIIIA alleles, unlike first generation anti-CTLA-4 molecules that generally benefit only those patients who express the high affinity allele |
| Reference | Wilky B et al. BOTENSILIMAB, A NOVEL INNATE/ADAPTIVE IMMUNE ACTIVATOR, PLUS OR MINUS BALSTILIMAB (ANTI-PD-1) IN “COLD” AND I-O REFRACTORY METASTATIC SOLID TUMORS SITC (2022) abstract 778 Wilky et al. Slide from presentation Bockorny B et al. Botensilimab, a novel innate/adaptive immune activator, plus balstilimab (anti-PD-1) in patients with recurrent platinum refractory/resistant ovarian cancer. SGO (2023) abstract 2 |