Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors
Summary
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
Detailed description
DS-3939a is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).
Arms & interventions
- DrugDS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
Outcome measures
Primary
Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a
Time frame: Approximately 3 months after first dosing
Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a
Time frame: Up to approximately 31 months
Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)
Time frame: Up to approximately 31 months
Secondary
Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1)
Time frame: Up to approximately 31 months
Disease Control Rate Following Treatment With DS-3939a
Time frame: Up to approximately 31 months
Duration of Response Following Treatment With DS-3939a
Time frame: Up to approximately 31 months
Time to Response Following Treatment With DS-3939a
Time frame: Up to approximately 31 months
Progression Free Survival Following Treatment With DS-3939a
Time frame: Up to approximately 31 months
Overall Survival Following Treatment With DS-3939a
Time frame: Up to approximately 31 months
TA-MUC1 Expression by Immunohistochemistry Following Treatment With DS-3939a
Time frame: At Cycle 1 Day 1
Area Under the Plasma Concentration Curve (AUC) Following Treatment With DS-3939a
Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) Following Treatment With DS-3939a
Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Time to Maximum Plasma Concentration (Tmax) Following Treatment With DS-3939a
Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Minimum Observed Concentration (Ctrough) Following Treatment With DS-3939a
Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Terminal Half-Life (T1/2) Following Treatment With DS-3939a
Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Number of Participants With Treatment-emergent Anti-drug Antibodies Following Treatment With DS-3939a
Time frame: Up to approximately 47 months
Eligibility criteria
Study locations (6)
Florida Cancer Specialists
Sarasota, Florida, 34232
Oregon Health & Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
The Medical College of Wisconsin, INC
Milwaukee, Wisconsin, 53226
References
- Takano K, Yukiura M, Takahashi K, Kitamura M, Okuno H, Shiose Y, Honda K, Oyama K, Yamada M, Obuchi W, Kumagai K, Sakurai K, Goto R, Zembutsu A, Kagari T, Abe Y, Agatsuma T. DS-3939a: A TA-MUC1-Directed Antibody-Drug Conjugate with Broad Antitumor Activity. Mol Cancer Ther. 2026 Jan 2;25(1):7-20. doi: 10.1158/1535-7163.MCT-24-0666.(PubMed)