A Study of DS-3939a in Participants With Solid Tumors (NCT07739966) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of DS-3939a in Participants With Solid Tumors
400 participantsStarted 2026-10-01
Plain-language summary
The primary purpose of the study is to evaluate the safety, tolerability, and efficacy of DS-3939a in combination with other anticancer agents or as a monotherapy in participants with 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
. Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.
. Adults greater than or equal to (≥)18 years of age at the time the Main Trial ICF is signed (follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old).
. Histologically documented Stage IIIB, IIIC disease who is not candidate for surgical resection or definitive chemoradiation, or Stage IV NSQ NSCLC.
. Has a left ventricular ejection fraction (LVEF) ≥50 percent (%) by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days of the first trial intervention.
. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 assessed no more than 14 days prior to initiation of trial interventions.
. Has adequate organ function.
. Participants must have measurable disease by investigator assessment according to RECIST v1.1.
. Participants with AGA (excluding EGFR mutation): Participants have been previously treated with targeted therapy for the AGA and platinum-based chemotherapy for the advanced disease setting.
Exclusion criteria
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
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Timeframe: During first cycle (Cycle length=21 days)
2
Part 1: Number of Participants With TEAEs
Timeframe: Up to approximately 4 years
3
Part 2: Objective Response (OR) Per RECIST v1.1 as Assessed by Investigator
Timeframe: Up to approximately 4 years
Trial details
NCT IDNCT07739966
SponsorDaiichi Sankyo
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2030-07-31
Contact for this trial
Daiichi Sankyo Contact for Clinical Trial Information
. Prior systemic anticancer therapy targeting MUC1 or TA-MUC1.
. Prior systemic anticancer therapy with topoisomerase 1 inhibitor or topoisomerase 1 inhibitor-based antibody-drug conjugate (ADCs) (e.g., datopotamab deruxtexan and Sacituzumab govitecan).
. Has spinal cord compression or clinically active central nervous system (CNS) metastases.
. Has multiple primary malignancies.
. Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening
. Has active or uncontrolled human immunodeficiency virus (HIV) infection.
. Has active or uncontrolled hepatitis B virus (HBV)/hepatitis C virus (HCV) infection.
. Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.