A Study of DS3610a in Participants With Advanced Solid Tumor

Last updated: November 21, 2025
Sponsor: Daiichi Sankyo
Overall Status: Active - Recruiting

Phase

1

Condition

Solid Tumors

Treatment

DS3610a

Clinical Study ID

NCT07159126
DS3610-071
2025-521173-13-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 localregulatory requirements if the legal age of consent for trial participation is >18years old).

  • Relapsed from, refractory to, or intolerant to appropriate therapies (eg, SoC) toprovide clinical benefit for their condition as assessed by their physician and/orinvestigator.

  • Is willing and able to provide an adequate pretreatment tissue sample prior to trialintervention or archival tumor tissue sample.

  • Has measurable disease based on local CT/MRI imaging as assessed by the investigatorper RECIST v1.1; radiographic tumor assessment must be performed within 28 daysprior to initiation of trial intervention.

Exclusion

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 exclusionaryprovided that, in the opinion of the investigator, the participant is neurologicallystable. MRI/CT of the brain is required for all participants during SCR Period

  • Uncontrolled or clinically significant cardiovascular disease, including thefollowing:

  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: cerebrovascularaccident, 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, anyunderlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trialenrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion,etc.) and any autoimmune, connective tissue, or inflammatory disorder with potentialpulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis,etc.), or prior pneumonectomy.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: DS3610a
Phase: 1
Study Start date:
November 09, 2025
Estimated Completion Date:
February 01, 2031

Study Description

This is a dose escalation study for participants with advanced or metastatic solid tumors. The primary objective of the study is to determine the Recommended Dose for Expansion (RDE), and to evaluate the safety, tolerability, PK, and preliminary efficacy of DS3610a in solid tumors.

Connect with a study center

  • National Cancer Center Hospital

    Chūōku 10262791, 104-0045
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa 1859924, 277-8577
    Japan

    Active - Recruiting

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