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 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.

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