DESTINY-Breast03 Phase 3 Study Results
Study Design
Dose Escalation (Part A)
DS-6000a IV q3w
RCC and serous OVC
Dose Expansion (Part B)
DS-6000a IV q3w at RDE
Cohort B-1
RCC
9.6 mg/kg
8.0 mg/kg
RDE
6.4 mg/kg
4.8 mg/kg
3.2 mg/kg
Cohort B-2
Serous OVC
1.6 mg/kg
Enrollment criteria
Primary objectives
Safety and tolerability
Determine MTD and RDE
Daiichi-Sankyo
•
Advanced/metastatic RCC or OVC not amenable to SOC therapya
.
•
ECOG PS 0 to 1
•
Ability to provide archived tissue for correlative testing
Secondary objectives
•
No previous treatment with CDH6-targeting agents or ADCs with a
linked topoisomerase I inhibitor
.
•
PK of DS-6000a, total anti-CDH6 antibody, and the DXd payload
Antitumor activity per RECIST 1.1
•
Immunogenicity
ADC, antibody drug conjugate; CDH6, cadherin 6; DXd, topoisomerase I inhibitor payload; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenous; MTD, maximum tolerated dose; OVC, ovarian cancer; PK,
pharmacokinetics; q3w, every 3 weeks; RCC, renal cell carcinoma, RDE, recommended dose for expansion; RECIST 1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SOC, standard of care.
a Patients with OVC must have also had prior treatment with platinum and taxane therapy.
ASCO 2022 #3002 Oral
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