Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

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


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, PFS, evaluated per RECIST


Doses 4.8-8.0 mg/kg:
ORR: 46% (1CR, 22PR)
DCR: 98% (1CR, 22PR, 4uPR, 22SD
DoR: 11.2 months
PFS: 7.9 months

Clinically Significant Adverse Events

Serious AE: 2 grade 5 ILD at dose 8.0 mg/kg - dose has been discontinued
Grade 3-4 AE: overall (36.7%), anemia (18.3%), decreased neutrophil counts (11.7%)


Raludotatug deruxtecan (DS-6000a) is generally well tolerated and demonstrates encouraging clinical activity in heavily pretreated Pt-R OC without CDH6 preselection


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

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