| Trial ID # | NCT05579366 |
| Phase | I/II |
| Drug Class | Antibody Drug Conjugates: FRalpha |
| Drug Name | Rinatabart sesutecan |
| Alternate Drug Names | PRO1184 |
| Drugs in Trial | Rinatabart sesutecan |
| Eligible Participant | Platinum resistant or refractory ovarian cancer |
| Patients Enrolled | 42, median 3 prior therapies (1-5); 93% Pt-R/Pt-Rf, 90% w/ prior bevacizumab, 66% w/ prior PARP inhibitor, 19% w/ prior mirvetuximab |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, DoR, evaluated per RECIST |
| Efficacy | 22 patients at 100 mg/m2 dose: 20 patients at 120 mg/m2 dose: |
| Clinically Significant Adverse Events | Serious AE: |
| Conclusion | Rinatabart sesutecan (Rina-S) is well tolerated with manageable side effects and promising anti-tumor activity is observed in ovarian cancer patients across a wide range of FRalpha expression levels |
| Reference | Lee EK et al. A phase I/II study of rinatabart sesutecan (Rina-S) in patients with advanced ovarian or endometrial cancer. Ann Oncol (2024) 35 (2) abstract 719MO |