Advanced Solid TumorPhase 1NCT07182591
A Study of DS5361b in Participants With Advanced Solid Tumors
A Phase 1 study testing DS5361b and Pembrolizumab in people with Advanced Solid Tumor, run by Daiichi Sankyo at 7 sites in 2 countries.
Trial summary
This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in 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
- Advanced Solid Tumor
- What is being tested?
- DS5361b and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 2 Oct 2025to 3 Dec 2030
- 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
- The clinical site will screen for the full inclusion criteria per protocol.
- 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).
- Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part 1 and Part 2 only).
- Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day 1. In Part 1 and Part 2, participants need to have documented TMB-H and/or MSI-H status. In Part 3, participants need to have documented TMB-H status.
- Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
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- Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention.
- For HNSCC participants only: have documented results from local testing of HPV for oropharyngeal cancer. If HPV status has previously been tested using this procedure, no retesting is required.
- Dose Expansion (Part 3) Only:
- Has histologically or cytologically confirmed, Stage IV NSCLC without actionable gene alteration.
- No prior systemic therapy.
- Participants with PD-L1 TPS ≥1%.
- Has histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.
- No prior systemic therapy administered in the recurrent or metastatic setting.
- Participants with PD-L1 CPS ≥1.
Who cannot join
- Has spinal cord compression or clinically active central nervous system metastases.
- Has a history of leptomeningeal carcinomatosis.
- Uncontrolled or significant cardiovascular disease.
- Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out.
- Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen).
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- Has any evidence of severe or uncontrolled systemic diseases.
- Has active or uncontrolled HBV infection. Hepatitis B SCR testing is required.
- Has active or uncontrolled HCV infection. Hepatitis C SCR testing is required.
- For the dose escalation phase (Part 1 and Part 2), has HIV infection. For the dose expansion part (Part 3), has active or uncontrolled HIV infection.
- Prior organ transplantation, including allogeneic stem cell transplantation.
- Has an active, known, or suspected autoimmune disease.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Recruiting
Research Site
Irving, Texas, 75039
- Recruiting
Research Site
Providence, Rhode Island, 02903
- Recruiting
Research Site
San Antonio, Texas, 78229
- Recruiting
Research Site
Sarasota, Florida, 34232
Japan2 sites, 2 recruiting
- Recruiting
Research Site
Kashiwa, 277-8577
- Recruiting
Research Site
Kōtoku, 135-8550
About this study
Official title: A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS5361b in Participants With Advanced Solid Tumors
This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- DS5361b, Pembrolizumab
- Keywords
- First-in-Human, Advanced Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS5361bDrug
Dose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE.
Dose Expansion Part: DS5361b will be administered at RDE.
PembrolizumabDrug
Also called Keytruda®
Dose Escalation Part: Pembrolizumab will be administered at a standard dose.
Dose Expansion Part: Pembrolizumab will be administered at a standard dose.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Monotherapy (Dose Escalation) | Experimental | Participants will receive DS5361b at escalating doses. Receives: Drug: DS5361b |
| Part 2: Combination Therapy (Dose Escalation) | Experimental | Participants will receive DS5361b at escalating doses in combination with Pembrolizumab. Receives: Drug: DS5361b; Drug: Pembrolizumab |
| Part 3: Combination Therapy (Dose Expansion) | Experimental | Participants will receive DS5361b in combination with Pembrolizumab at the recommended dose for expansion (RDE). Receives: Drug: DS5361b; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and 2: Number of participants with Dose-Limiting Toxicities (DLTs)
A DLT is defined as any Treatment Emergent Adverse Event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc, that occurs during the DLT evaluation period (Day 1 to the end of Cycle 1) and is Grade ≥3.
Measured: Cycle 1: Day 1 up to Day 21 (each cycle is 21 days)
Part 1, 2, and 3: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 30 days after the last dose date of trial intervention).
Measured: From Screening up to approximately 5 years
Part 3 Only: Objective Response Rate (ORR) Following the Administration of DS5361b at RDE(s) in Combination with Pembrolizumab
ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by investigator per RECIST v1.1.
Measured: From first dose up to approximately 5 years
Secondary outcomes (7)
Maximum Plasma Concentration (Cmax) of DS5361b
Measured: Cycle 1: Day 1, Day 15 (each cycle is 21 days)
Time to Reach Maximum Plasma Concentration (Tmax) of DS5361b
Measured: Cycle 1: Day 1, Day 15 (each cycle is 21 days)
Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) of DS5361b
Measured: Cycle 1: Day 1 (each cycle is 21 days)
Trough Plasma Concentration (Ctrough) of DS5361b
Measured: Cycle 1: Day 15 (each cycle is 21 days)
Part 1 and 2: Objective Response Rate (ORR) Following the Administration of DS5361b Alone and in Combination with Pembrolizumab
ORR is defined as the proportion of participants with a BOR of confirmed CR or PR, as assessed by investigator per RECIST v1.1.
Measured: From first dose up to approximately 5 years
Disease Control Rate (DCR) Following Administration of DS5361b Alone and in Combination with Pembrolizumab
DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease as assessed by investigator per RECIST v1.1.
Measured: From first dose up to approximately 5 years
Duration of Response (DoR) Following Administration of DS5361b Alone and in Combination with Pembrolizumab
DoR is defined as the time (in months) from date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression or death due to any cause.
Measured: From first dose up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start2 Oct 2025
- Primary completion18 Mar 2030 (estimated)
- Study completion3 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 192 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
- NCT07182591
- Sponsor's protocol ID
- DS5361-061
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2025
- Last updated
- 2 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 2 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 DS5361b in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07182591
- Acronym / sponsor ID
- DS5361-061
- Conditions
- Advanced Solid Tumor
- Keywords
- First-in-Human, Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 18 Mar 2030 (estimated)
- Study completion
- 3 Dec 2030 (estimated)
- First posted
- 19 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 aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Monotherapy (Dose Escalation) | Experimental | Drug: DS5361bParticipants will receive DS5361b at escalating doses. |
| Part 2: Combination Therapy (Dose Escalation) | Experimental | Drug: DS5361b, Drug: PembrolizumabParticipants will receive DS5361b at escalating doses in combination with Pembrolizumab. |
| Part 3: Combination Therapy (Dose Expansion) | Experimental | Drug: DS5361b, Drug: PembrolizumabParticipants will receive DS5361b in combination with Pembrolizumab at the recommended dose for expansion (RDE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The clinical site will screen for the full inclusion criteria per protocol.
- 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).
- Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part 1 and Part 2 only).
- Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day 1. In Part 1 and Part 2, participants need to have documented TMB-H and/or MSI-H status. In Part 3, participants need to have documented TMB-H status.
- Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1.
Key exclusion criteria (13 listed)
- Has spinal cord compression or clinically active central nervous system metastases.
- Has a history of leptomeningeal carcinomatosis.
- Uncontrolled or significant cardiovascular disease.
- Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out.
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 |
|---|---|---|
| DS5361bDose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE. Dose Expansion Part: DS5361b will be administered at RDE. | Drug | Part 1: Monotherapy (Dose Escalation), Part 2: Combination Therapy (Dose Escalation), Part 3: Combination Therapy (Dose Expansion) |
| PembrolizumabAlso: Keytruda®Dose Escalation Part: Pembrolizumab will be administered at a standard dose. Dose Expansion Part: Pembrolizumab will be administered at a standard dose. | Drug | Part 2: Combination Therapy (Dose Escalation), Part 3: Combination Therapy (Dose Expansion) |
Primary outcome
Part 1 and 2: Number of participants with Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1: Day 1 up to Day 21 (each cycle is 21 days)
A DLT is defined as any Treatment Emergent Adverse Event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc, that occurs during the DLT evaluation period (Day 1 to the end of Cycle 1) and is Grade ≥3.
Part 1, 2, and 3: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
Time frame: From Screening up to approximately 5 years
TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 30 days after the last dose date of trial intervention).
Part 3 Only: Objective Response Rate (ORR) Following the Administration of DS5361b at RDE(s) in Combination with Pembrolizumab
Time frame: From first dose up to approximately 5 years
ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by investigator per RECIST v1.1.
7 secondary outcomes
Maximum Plasma Concentration (Cmax) of DS5361b
Time frame: Cycle 1: Day 1, Day 15 (each cycle is 21 days)
Time to Reach Maximum Plasma Concentration (Tmax) of DS5361b
Time frame: Cycle 1: Day 1, Day 15 (each cycle is 21 days)
Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) of DS5361b
Time frame: Cycle 1: Day 1 (each cycle is 21 days)
Trough Plasma Concentration (Ctrough) of DS5361b
Time frame: Cycle 1: Day 15 (each cycle is 21 days)
Part 1 and 2: Objective Response Rate (ORR) Following the Administration of DS5361b Alone and in Combination with Pembrolizumab
Time frame: From first dose up to approximately 5 years
Disease Control Rate (DCR) Following Administration of DS5361b Alone and in Combination with Pembrolizumab
Time frame: From first dose up to approximately 5 years
Duration of Response (DoR) Following Administration of DS5361b Alone and in Combination with Pembrolizumab
Time frame: From first dose up to approximately 5 years
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 2 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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DS5361b and Pembrolizumab in people with Advanced Solid Tumor, run by Daiichi Sankyo at 7 sites in 2 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 15 inclusion and 13 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 2 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 7 sites in United States, Japan. 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?
Part 1 and 2: Number of participants with Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1: Day 1 up to Day 21 (each cycle is 21 days)). The study lists 3 primary outcomes in all. 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 2 Sep 2026.