A Study of DS3610a in Participants With Advanced Solid Tumor

NCT07159126 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: DS3610-0712025-521173-13-00
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Tumors; Metastatic Solid Tumors

Keywords

DS3610a

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities

  From first dose, up to approximately 24 months

Secondary Outcomes (2)

• Area Under the Blood Concentration-time Curve During Dosing Interval

  From baseline to postbaseline, up to approximately 36 months

• Antidrug Antibody Prevalence

  From baseline to postbaseline, up to approximately 36 months

Study Arms (1)

DS3610a at Escalating Doses

EXPERIMENTAL

Participants will receive DS3610a at escalating doses. The RDE will be determined using data collected from this arm.

Drug: DS3610a

Interventions

DS3610a DRUG

Participants will receive DS3610a at the target dose. Treatment will continue until radiographic disease progression, as determined by the investigator, or until another reason for discontinuation of trial intervention occurs.

DS3610a at Escalating Doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \*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
• Uncontrolled or clinically significant cardiovascular disease, including the following:
• Myocardial infarction within 6 months prior to SCR.
• Uncontrolled angina pectoris within 6 months prior to SCR.
• New York Heart Association (NYHA) Class III or IV CHF.
• LVEF ≤50%.
• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (2)

National Cancer Center Hospital

Chūōku, 104-0045, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

RECRUITING

Central Study Contacts

Contact for Trial Information

CONTACT

908-992-6400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): February 1, 2031
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (2)