NCT07739966 · Daiichi Sankyo
A Study of DS-3939a in Participants With Solid Tumors
What this study is about
The primary purpose of the study is to evaluate the safety, tolerability, and effectiveness of DS-3939a in combination with other anticancer agents or as a treatment given alone in participants with solid tumors.
View original scientific description
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.
Interventions
DRUG
DS-3939a
DS-3939a will be administered as an IV infusion.
DRUG
Pembrolizumab
Pembrolizumab will be administered as an IV infusion.
DRUG
Carboplatin
Carboplatin will be administered as an IV infusion.
DRUG
Pemetrexed
Pemetrexed will be administered as an IV infusion.
DRUG
DS-1103a
DS-1103a will be administered as an IV infusion.
Primary outcome measures
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: During first cycle (Cycle length=21 days)
DLT is defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc., that occurs during the DLT-evaluation Period (Day 1 to the end of Cycle 1) and is Grade ≥3. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Part 1: Number of Participants With TEAEs
Time frame: Up to approximately 4 years
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 50 days after the last dose date of trial intervention, unless otherwise specified in the applicable sub-study protocol).
Part 2: Objective Response (OR) Per RECIST v1.1 as Assessed by Investigator
Time frame: Up to approximately 4 years
OR is defined as participants with a best overall response (BOR) of confirmed response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST v1.1.
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 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. Additional Inclusion Criteria for Substudy 1: 1\. Participants must not have received prior systemic therapy for locally advanced unresectable or metastatic NSCLC. Additional Inclusion Criteria for Substudy 2:
- 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.
- Participants without AGA: Participants have been previously treated with platinum-based chemotherapy and anti-programmed death-1 (anti-PD-1)/programmed death-ligand 1 (PD-L1) antibody
- Part 2 only: Participants must have received only 1 or 2 prior lines of anticancer therapy for the advanced disease setting.
Exclusion criteria
- 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.
- Current participation in other therapeutic investigational procedures, except for participation in long term survival follow-up (LTSFU) without any investigational treatment.
Where
- Fayetteville, Arkansas
- Los Angeles, California
- Tampa, Florida
- Portland, Oregon
- Providence, Rhode Island
- Houston, Texas
- Fairfax, Virginia
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 Oct 28, 2026 · Source of record for eligibility and locations