NCT05875168 · Daiichi Sankyo
First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
What this study is about
This study will evaluate the safety, tolerability, and effectiveness of DS-3939a in participants with advanced solid tumors.
View original scientific description
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
Interventions
DRUG
DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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 Scre
Where
- Sarasota, Florida
- Portland, Oregon
- Providence, Rhode Island
- Houston, Texas
- Salt Lake City, Utah
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations