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NCT07159126 · Daiichi Sankyo

A Study of DS3610a in Participants With Advanced Solid Tumor

What this study is about

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

View original scientific description

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.

Interventions

DRUG

DS3610a

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.

Primary outcome measures

Dose Limiting Toxicities

Time frame: From first dose, up to approximately 24 months

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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:
  • 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.
  • 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

  • Milwaukee, Wisconsin

Related conditions & keywords

Solid TumorsMetastatic Solid TumorsDS3610a

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Sep 18, 2026 · Source of record for eligibility and locations

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1 of 70 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Milwaukee

Wisconsin

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Advanced Solid Tumors Trials by City

Browse all advanced solid tumors clinical trials in these cities — not just this study.

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Looking for Solid Tumors Treatment in Milwaukee?

Join others in Wisconsin exploring innovative treatment options through clinical research

Solid Tumors Treatment Options in Milwaukee, Wisconsin

If you're searching for Solid Tumors treatment in Milwaukee, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Milwaukee and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Solid Tumors. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Wisconsin
Now Enrolling
Up to 70 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Solid Tumors?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Solid Tumors

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Solid Tumors Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07159126. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.