DS3610a for adults with advanced or metastatic solid tumors
Official title: A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor
Run by Daiichi Sankyo · NCT07159126 · Data updated 2026-11-12
This trial will test whether DS3610a is safe and helps adults with advanced or metastatic solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Daiichi Sankyo Industry-sponsored |
| Drugs / interventions | Chemotherapy, immunotherapy, radiation |
| Locations | 4 sites (Milwaukee, Wisconsin and 3 other locations) |
| Status | Recruiting |
| Started | October 9, 2025 |
| Main results expected | September 1, 2028 |
| Study ends | February 1, 2031 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07159126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with advanced or metastatic solid tumors who have measurable disease, have relapsed on or are intolerant of standard therapies, and can provide a tumor tissue sample are the ideal candidates.
✕Probably not a fit
Patients who still have effective standard therapy options, cannot provide the required tissue sample, have recent major surgery or other exclusion conditions, or fail required washout periods are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, single‑agent dose‑escalation trial of DS3610a in adults with advanced or metastatic solid tumors. The study aims to find the Recommended Dose for Expansion (RDE) while monitoring safety, tolerability, and pharmacokinetics, and to look for early signs of tumor response. Participants must have measurable disease per RECIST v1.1 and provide a pretreatment or archival tumor tissue sample. Radiographic assessments are performed within 28 days before starting treatment and standard washout periods and eligibility criteria apply.
Why it matters
Potential benefit: If successful, DS3610a could offer a new treatment option that controls tumor growth with an acceptable safety profile for people with advanced solid tumors.
How similar studies have gone: Phase 1 single‑agent dose‑escalation trials of novel oncology drugs have sometimes shown promising early activity, but DS3610a itself is a novel agent with limited prior human data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Sign and date the main ICF, prior to the start of any trial-specific procedures. * Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old). * Relapsed from, refractory to, or intolerant to appropriate therapies (eg, SoC) to provide clinical benefit for their condition as assessed by their physician and/or investigator. * Is willing and able to provide an adequate pretreatment tissue sample prior to trial intervention or archival tumor tissue sample. * Has measurable disease based on local CT/MRI imaging as assessed by the investigator per RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention. Key Exclusion Criteria: \*Inadequate washout period before initiation of trial intervention, defined as: Major surgery: ≤4 weeks (or ≤2 weeks for low-invasive cases) Curative radiation therapy: ≤4 weeks Chemotherapy, Ab-based anticancer therapy, immunotherapy: ≤4 weeks Small molecules (eg, tyrosine kinase inhibitors): ≤2 weeks or 5 half-lives, whichever is longer Nitrosoureas: ≤6 weeks * Has known symptomatic CNS metastases, leptomeningeal disease, or cord compression. Note: Asymptomatic or adequately treated CNS metastases are not exclusionary provided that, in the opinion of the investigator, the participant is neurologically stable. MRI/CT of the brain is required for all participants during SCR Period * Uncontrolled or clinically significant cardiovascular disease, including the following: 1. Myocardial infarction within 6 months prior to SCR. 2. Uncontrolled angina pectoris within 6 months prior to SCR. 3. New York Heart Association (NYHA) Class III or IV CHF. 4. LVEF ≤50%. 5. QTcF interval \>470 ms. * Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic events. * Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen) resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
Where it's running
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Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States Recruiting -
Oncopole Claudius Regaud
Toulouse, France Recruiting -
National Cancer Center Hospital
Chūōku, Japan Recruiting -
National Cancer Center Hospital East
Kashiwa, Japan Recruiting
Study contacts
- Study coordinator: Contact for Trial Information
- Email: CTRinfo_us@daiichisankyo.com
- Phone: 908-992-6400
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.