Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07159126

A Study of DS3610a in Participants With Advanced Solid Tumor

Led by Daiichi Sankyo · Updated on 2025-12-10

70

Participants Needed

2

Research Sites

277 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.

CONDITIONS

Official Title

A Study of DS3610a in Participants With Advanced Solid Tumor

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older at the time of consent
  • Participants with relapsed, refractory, or intolerant advanced or metastatic solid tumors
  • Willing and able to provide an adequate pretreatment or archival tumor tissue sample
  • Measurable disease on CT or MRI imaging performed within 28 days before starting treatment
  • Signed and dated informed consent form prior to any trial-specific procedures
Not Eligible

You will not qualify if you...

  • Inadequate washout period before starting treatment, including: major surgery within 4 weeks (or 2 weeks for low-invasive cases), curative radiation therapy within 4 weeks, chemotherapy/antibody/immunotherapy within 4 weeks, small molecules within 2 weeks or 5 half-lives, nitrosoureas within 6 weeks
  • Known symptomatic central nervous system metastases, leptomeningeal disease, or cord compression (asymptomatic or treated CNS metastases allowed if neurologically stable)
  • Uncontrolled or clinically significant cardiovascular disease, including myocardial infarction or unstable angina within 6 months, NYHA Class III or IV congestive heart failure, left ventricular ejection fraction ≤50%, or QTcF interval >470 ms
  • History of cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic events within 6 months prior to enrollment
  • Clinically severe lung problems requiring supplemental oxygen or related to serious pulmonary disorders or autoimmune diseases affecting the lungs, or prior pneumonectomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

C

Contact for Trial Information

CONTACT

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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