Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors
Daiichi Sankyo
Summary
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugDS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
Locations (33)
- Florida Cancer SpecialistsSarasota, Florida
- Oregon Health & Science UniversityPortland, Oregon
- Rhode Island HospitalProvidence, Rhode Island
- University of Texas M.D. Anderson Cancer CenterHouston, Texas
- Huntsman Cancer Institute, University of UtahSalt Lake City, Utah
- The Medical College of Wisconsin, INCMilwaukee, Wisconsin