| Trial ID # | NCT04707248 |
| Phase | I |
| Drug Class | Antibody Drug Conjugates: CDH6 |
| Drug Name | Raludotatug deruxtecan |
| Alternate Drug Names | DS-6000a |
| Drugs in Trial | Raludotatug deruxtecan |
| Eligible Participant | Platinum resistant or refractory ovarian cancer |
| Patients Enrolled | 60 patients, median 4 prior therapies (1-13), 92% Pt-R |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, DoR, PFS, evaluated per RECIST |
| Efficacy | Doses 4.8-8.0 mg/kg: |
| Clinically Significant Adverse Events | Serious AE: 2 grade 5 ILD at dose 8.0 mg/kg - dose has been discontinued |
| Conclusion | Raludotatug deruxtecan (DS-6000a) is generally well tolerated and demonstrates encouraging clinical activity in heavily pretreated Pt-R OC without CDH6 preselection |
| Reference | Hamilton EP et al. Phase I, two-part, multicenter, first-in-human (FIH) study of DS-6000a in subjects with advanced renal cell carcinoma (RCC) and ovarian tumors (OVC). J Clin Oncol 40, 2022 (suppl 16; abstr 3002) Hamilton EP et al. Slide from presentation Moore KN et al. Raludotatug deruxtecan (R-DXd; DS-6000) monotherapy in patients with previously treated ovarian cancer (OVC): Subgroup analysis of a first-in-human phase I study. Ann Oncol (2023) 34(2) abstract 745MO Moore KN et al. Slide from presentation |