Solid TumorsPhase 1NCT07159126
A Study of DS3610a in Participants With Advanced Solid Tumor
A Phase 1 study testing DS3610a in people with Solid Tumors and Metastatic Solid Tumors, run by Daiichi Sankyo at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- DS3610a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 9 Oct 2025to 1 Feb 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital
Chūōku, 104-0045
- Recruiting
National Cancer Center Hospital East
Kashiwa, 277-8577
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor
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.
Read the detailed 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.
- Conditions
- Solid Tumors, Metastatic Solid Tumors
- Being tested
- DS3610a
- Keywords
- DS3610a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS3610aDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| DS3610a at Escalating Doses | Experimental | Participants will receive DS3610a at escalating doses.
The RDE will be determined using data collected from this arm. Receives: Drug: DS3610a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
Measured: From first dose, up to approximately 24 months
Secondary outcomes (2)
Area Under the Blood Concentration-time Curve During Dosing Interval
Area Under the Blood Concentration-time Curve During Dosing Interval (AUCtau) will be used to asses PK parameters
Measured: From baseline to postbaseline, up to approximately 36 months
Antidrug Antibody Prevalence
The percentage of participants who are Antidrug Antibody positive at any point in time.
Measured: From baseline to postbaseline, up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start9 Oct 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159126
- Sponsor's protocol ID
- DS3610-071
- Other IDs
- 2025-521173-13-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT07159126
- Acronym / sponsor ID
- DS3610-071
- Conditions
- Solid Tumors, Metastatic Solid Tumors
- Keywords
- DS3610a
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS3610a at Escalating Doses | Experimental | Drug: DS3610aParticipants will receive DS3610a at escalating doses. The RDE will be determined using data collected from this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (10 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS3610aParticipants 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. | Drug | DS3610a at Escalating Doses |
Primary outcome
Dose Limiting Toxicities
Time frame: From first dose, up to approximately 24 months
2 secondary outcomes
Area Under the Blood Concentration-time Curve During Dosing Interval
Time frame: From baseline to postbaseline, up to approximately 36 months
Antidrug Antibody Prevalence
Time frame: From baseline to postbaseline, up to approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DS3610a in people with Solid Tumors and Metastatic Solid Tumors, run by Daiichi Sankyo at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan, United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Contact for Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (time frame: From first dose, up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.