First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
- Registration Number
- NCT05875168
- Lead Sponsor
- Daiichi Sankyo
- Brief 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 470
- Sign and date the main Informed Consent Form (ICF).
- Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.
- Has adequate organ function.
- Measurable disease based on RECIST V1.1.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
Additional inclusion criteria for Part 1
- Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.
Additional inclusion criteria for Part 2
-
Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy.
-
Is able to provide either of the following baseline tumor samples:
- Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or
- Fresh core needle biopsy sample
- Biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy (if the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual)
- FFPE tumor tissue samples obtained by biopsy or surgery performed after the completion date of the most recent anticancer therapy regimen and within 6 months before signing the ICF
- Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
- Has spinal cord compression or history of/clinically active central nervous system metastases.
- Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.
- Has a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- Has active or uncontrolled human immunodeficiency virus (HIV) infection.
- Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection.
- Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- Has an active, known, or suspected autoimmune disease.
- Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation (Part 1) DS-3939a Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a. Dose Expansion (Part 2) DS-3939a Multiple expansion cohorts targeting various advanced solid tumors.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a Approximately 3 months after first dosing Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a Up to approximately 31 months Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2) Up to approximately 31 months
- Secondary Outcome Measures
Name Time Method Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1) Up to approximately 31 months Maximum Plasma Concentration (Cmax) Following Treatment With DS-3939a 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) Disease Control Rate Following Treatment With DS-3939a Up to approximately 31 months Duration of Response Following Treatment With DS-3939a Up to approximately 31 months Overall Survival Following Treatment With DS-3939a Up to approximately 31 months Area Under the Plasma Concentration Curve (AUC) Following Treatment With DS-3939a 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 Response Following Treatment With DS-3939a Up to approximately 31 months Progression Free Survival Following Treatment With DS-3939a Up to approximately 31 months TA-MUC1 Expression by Immunohistochemistry Following Treatment With DS-3939a At Cycle 1 Day 1 Time to Maximum Plasma Concentration (Tmax) Following Treatment With DS-3939a 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 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 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 Up to approximately 47 months
Trial Locations
- Locations (24)
McGill University Health Center
🇨🇦Montreal, Canada
Princess Margaret Cancer Center
🇨🇦Toronto, Canada
Shanghai East Hospital
🇨🇳Shanghai, China
Kansai Medical University Hospital
🇯🇵Hirakata-shi, Japan
Florida Cancer Specialists
🇺🇸Sarasota, Florida, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
University of Texas M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute, University of Utah
🇺🇸Salt Lake City, Utah, United States
The Medical College of Wisconsin, INC
🇺🇸Milwaukee, Wisconsin, United States
UZ Leuven
🇧🇪Leuven, Belgium
Centre Léon Bérard
🇫🇷Lyon, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut Gustave Roussy
🇫🇷Villejuif cedex, France
National Cancer Center Hospital
🇯🇵Chuo-ku, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Japan
Cancer Institute Hospital of Jfcr
🇯🇵Koto-ku, Japan
Kindai University Hospital
🇯🇵Osaka-Sayama, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Universitari Vall D'Hebron
🇪🇸Barcelona, Spain
Next Madrid
🇪🇸Pozuelo de Alarcón, Spain