DS3610a for adults with advanced or metastatic solid tumors

A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor

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
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Daiichi Sankyo (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Chūōku and 1 other locations)
• Trial ID: NCT07159126 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Chūōku and 1 other locations

• National Cancer Center Hospital — Chūōku, Japan (Recruiting)
• National Cancer Center Hospital East — Kashiwa, Japan (Recruiting)

Study contacts

• Study coordinator: Contact for Trial Information

Conditions Solid Tumors; Metastatic Solid Tumors; DS3610a