First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors (NCT05875168) | Clinical Trial Compass
RecruitingPhase 1/2
First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
United States, Belgium, Canada590 participantsStarted 2023-08-18
Plain-language summary
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or
. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a
Timeframe: Approximately 3 months after first dosing
2
Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a
Timeframe: Up to approximately 31 months
3
Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)
Timeframe: Up to approximately 31 months
4
PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only)
Timeframe: Up to approximately 31 months
Trial details
NCT IDNCT05875168
SponsorDaiichi Sankyo
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2026-10-20
Contact for this trial
(US Sites) Daiichi Sankyo Contact for Clinical Trial Information