DS5361b + Pembrolizumab for Cancer

Recruiting at 1 trial location

Overseen By Contact for Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Daiichi Sankyo

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: CNS metastases, Cardiovascular disease, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new drug, DS5361b (experimental treatment), both alone and with pembrolizumab (an immunotherapy drug), to determine its safety and effectiveness for individuals with difficult-to-treat advanced solid tumors. The study targets those whose cancer has not responded to other treatments or for whom no standard options exist. Participants should have a specific type of cancer that cannot be surgically removed and has recurred or spread, with certain genetic markers such as TMB-H or MSI-H. For those with advanced cancer where treatments have failed, this trial might be suitable. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. However, if you are on systemic steroid therapy or any other form of immunosuppressive therapy, you must stop it at least 14 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DS5361b is being tested for safety and tolerability when combined with pembrolizumab. This Phase 1 study focuses on determining the treatment's safety for humans and aims to find the highest dose that can be taken without serious side effects.

Clear information on side effects from earlier studies is lacking. However, pembrolizumab's FDA approval for other uses indicates that its safety profile is well understood. For DS5361b, there is not yet enough information to determine its tolerability alone or with pembrolizumab.

Overall, this study is in its early stages. It primarily seeks to understand how the body responds to the treatment, and more safety information will emerge as more participants join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about DS5361b and Pembrolizumab because these treatments offer a fresh approach to tackling cancer. Unlike traditional therapies that may focus on killing cancer cells directly, DS5361b is designed to work in tandem with Pembrolizumab, a known immunotherapy, to enhance the body's immune response against cancer. DS5361b acts on specific targets within cancer cells, potentially offering a more precise attack with fewer side effects. This combination aims to not only improve efficacy but also expand the range of cancers that can be effectively treated with immunotherapy, making it a promising option for patients and clinicians alike.

What evidence suggests that this trial's treatments could be effective for advanced or metastatic solid tumors?

In this trial, participants will receive either DS5361b alone or combined with Pembrolizumab. Research studies have shown that Pembrolizumab produces promising results in treating various cancers. For example, patients treated with Pembrolizumab achieved a 5-year overall survival rate of 31.9%, surpassing those who received chemotherapy. DS5361b remains under investigation for its potential to treat advanced solid tumors. Researchers aim to determine whether combining DS5361b with Pembrolizumab can enhance treatment effectiveness. Early tests in this trial seek to confirm if this combination can improve tumor response to treatment. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced or metastatic solid tumors. Specific eligibility criteria are not provided, but typically participants must have a measurable disease, adequate organ function, and no prior adverse reactions to similar treatments.

Inclusion Criteria

For Dose Expansion (Part 3) Only:

Participants with PD-L1 TPS ≥1%

Participants with PD-L1 positive defined by CPS ≥1

Exclusion Criteria

Has an active, known, or suspected autoimmune disease

I have had an organ or stem cell transplant.

I do not have serious heart problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1: Monotherapy (Dose Escalation)

Participants receive DS5361b at escalating doses

3 weeks per cycle

1 visit per cycle (in-person)

Treatment - Part 2: Combination Therapy (Dose Escalation)

Participants receive DS5361b at escalating doses in combination with Pembrolizumab

3 weeks per cycle

1 visit per cycle (in-person)

Treatment - Part 3: Combination Therapy (Dose Expansion)

Participants receive DS5361b in combination with Pembrolizumab at the recommended dose for expansion

3 weeks per cycle

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• DS5361b
• Pembrolizumab

Trial Overview The study is testing the safety and initial effectiveness of DS5361b alone and in combination with pembrolizumab. It also aims to find the maximum tolerated dose (MTD) of DS5361b when used as monotherapy or alongside pembrolizumab.

How Is the Trial Designed?

Group I: Part 3: Combination Therapy (Dose Expansion) Experimental Treatment 2 Interventions

Participants will receive DS5361b in combination with Pembrolizumab at the recommended dose for expansion (RDE).

Group II: Part 2: Combination Therapy (Dose Escalation) Experimental Treatment 2 Interventions

Participants will receive DS5361b at escalating doses in combination with Pembrolizumab.

Group III: Part 1: Monotherapy (Dose Escalation) Experimental Treatment 1 Intervention

Participants will receive DS5361b at escalating doses.

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07182591

A Study of DS5361b in Participants With Advanced Solid ... This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with ...

2. ctv.veeva.com ctv.veeva.com/study/a-study-of-ds5361b-in-participants-with-advanced-solid-tumors

A Study 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 ...

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/DSKYF/pressreleases/35744164/daiichi-sankyos-latest-clinical-trial-a-new-hope-for-advanced-solid-tumors/

Daiichi Sankyo's Latest Clinical Trial: A New Hope for ... DS5361b is being assessed for its potential to treat advanced solid tumors, while pembrolizumab is a well-known immunotherapy drug used to ...

4. jnj.com jnj.com/media-center/press-releases/johnson-johnson-enters-new-era-in-solid-tumors-at-esmo-2025-with-promising-data-across-multiple-cancer-types

Johnson & Johnson enters new era in solid tumors at ... First report of subcutaneous amivantamab demonstrates compelling clinical activity in recurrent or metastatic head and neck cancer, ...

5. trialx.com trialx.com/clinical-trials/listings/location/international/Korea,%20Republic%20of/Seoul,%20etc./?page=1338

Seoul, etc., Korea, Republic of Clinical Research Trials This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with ...

6. withpower.com withpower.com/trial/phase-1-solid-tumors-advanced-solid-tumors-8-2025-d5981

DS5361b + Pembrolizumab for Cancer This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with ...

7. meddatax.com meddatax.com/clinical-trials/NCT07182591

A Study 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 ...

8. cri.careboxhealth.com cri.careboxhealth.com/en-US/trials

View Studies - CRI Clinical Trial Finder This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma ... LTZ Therapeutics, Inc.