Actively Recruiting
A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor
Led by Daiichi Sankyo · Updated on 2025-12-10
70
Participants Needed
2
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the safety, tolerability, and initial effectiveness of DS3610a in adults with advanced or metastatic solid tumors. The study is a phase 1, open-label trial focusing on determining the recommended dose for further expansion, while also evaluating how the drug behaves in the body and its preliminary benefits. Participants have solid tumors that have progressed despite prior treatments or who cannot tolerate standard therapies. Participants will receive DS3610a at increasing doses to find the optimal dose level. Treatment continues until the tumor shows progression on imaging or another reason requires stopping. This dose escalation phase collects data to set the recommended dose for future studies, monitoring participants closely throughout. The study does not include a placebo group and is non-randomized. During the trial, participants will undergo assessments including scans to measure tumor size, blood tests to monitor drug levels and immune responses, and evaluations for side effects. The primary outcome is monitoring dose-limiting toxicities for up to 24 months, with additional measures over 36 months. Participation involves regular visits for treatment and safety checks, lasting as long as treatment continues or until disease progression occurs.
CONDITIONS
Brief Title
A Study of DS3610a in Participants With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older at the time of consent
- Have relapsed from, are refractory to, or intolerant of standard therapies for their solid tumor
- Willing and able to provide an adequate pretreatment or archival tumor tissue sample
- Have measurable disease based on recent CT or MRI scans within 28 days prior to trial treatment
- Signed and dated informed consent form prior to any trial procedures
You will not qualify if you...
- Inadequate washout period before starting trial treatment (e.g., major surgery within 4 weeks, chemotherapy or immunotherapy within 4 weeks, or small molecule therapy within 2 weeks or 5 half-lives)
- Known symptomatic central nervous system metastases, leptomeningeal disease, or spinal cord compression (neurologically unstable)
- Uncontrolled or significant cardiovascular disease including recent myocardial infarction, uncontrolled angina, severe heart failure, low ejection fraction, or prolonged QT interval
- History of stroke, transient ischemic attack, or arterial thromboembolic events within 6 months prior to enrollment
- Severe lung problems requiring supplemental oxygen or related autoimmune or inflammatory lung disorders
- Prior pneumonectomy (lung removal)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until radiographic disease progression or discontinuation
Participants receive the study drug DS3610a at escalating doses until disease progression or other reasons for stopping treatment.
Visits occur throughout treatment for dosing and safety monitoring
Trial Site Locations
Total: 2 locations
1
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
2
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
Research Team
C
Contact for Trial Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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