This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.
This is a first-in-human, phase 1, dose escalation study of the anti-CLDN6 ADC, DS-9606a, given as a single agent to patients with solid tumors. The primary objectives are to investigate the safety and tolerability of DS-9606a and to determine the maximum tolerated dose (MTD) and recommended doses for expansion (RDE/RDEs) in advanced solid tumors. The secondary objectives of the study are to assess the pharmacokinetic properties and immunogenicity of DS-9606a, investigate the objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR) and progression free survival (PFS) of DS-9606a, according to RECIST v1.1.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Intravenous infusion
SCRI at HealthONE
Denver, Colorado, United States
Florida Cancer Specialists & Research Institute, LLC
Fort Myers, Florida, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a
Time frame: Cycle 1 Day 1 through Day 21 of Cycle 2 (each cycle is 21 days)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-9606a
Time frame: Cycle 1 Day 1 to 90 days after last dose, up to 42 months (each cycle is 21 days)
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days)
Pharmacokinetic Parameter Maximum Concentration (Cmax)
Time frame: Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days)
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
Time frame: Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days)
Pharmacokinetic Parameter Trough Concentration (Ctrough)
Time frame: Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days)
Overall Response Rate of DS-9606a as Assessed by the Investigator in Participants Receiving DS-9606a
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MD Anderson Cancer Center
Houston, Texas, United States
Sarah Cannon Research Institute UK
London, United Kingdom
The Royal Marsden NHS Trust
Sutton, United Kingdom
Time frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days)
Duration of Response (DoR) as Assessed by the Investigator in Participants Receiving DS-9606a
Time frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days)
Disease Control Rate (DCR) as Assessed by the Investigator in Participants Receiving DS-9606a
Time frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days)
Time to Response (TTR) as Assessed by the Investigator in Participants Receiving DS-9606a
Time frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days)
Progression-free Survival (PFS) as Assessed by the Investigator in Participants Receiving DS-9606a
Time frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days)
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Percentage of Participants Who Have Treatment-emergent ADA
Time frame: Cycle 1 Days 1 and 15, Cycles 2 and 3 Day 1, Cycle 4 Day 1 and every 4 cycles thereafter on Day 1, up to 42 months (each cycle is 21 days)