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Brief Title: A Study of DS-9606a in Patients With Advanced Solid Tumors
Official Title: A Phase 1, First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 (CLDN6)
Study ID: NCT05394675
Brief Summary: This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.
Detailed Description: This first-in-human, phase 1 study will consist of 2 parts. In Part A (Dose Escalation), the primary objectives will be to investigate the safety and tolerability of DS-9606a in advanced solid tumors and to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE). In Part B (Dose Expansion), the safety and tolerability of DS-9606a will be further explored and the overall response rate will be assessed. The secondary objectives of the study will assess pharmacokinetic properties of DS-9606a and investigate the duration of response and progression-free survival of DS-9606a, and assess the immunogenicity of DS-9606a.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
SCRI at HealthONE, Denver, Colorado, United States
Florida Cancer Specialists & Research Institute, LLC, Sarasota, Florida, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
The Royal Marsden NHS Trust, London, , United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom
Name: Clinical Director
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR