DS-3939a for Advanced Solid Tumors

Recruiting at 26 trial locations

Overseen By (Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Daiichi Sankyo

Disqualifiers: CNS metastases, ILD, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

470 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

This trial is for adults with advanced solid tumors, including specific types such as urothelial, lung, breast, ovarian, biliary tract cancers or pancreatic cancer. Participants must have measurable disease and be in good physical condition (performance status of 0 or 1). They should not have autoimmune diseases, other ongoing clinical study commitments, prior treatments targeting MUC1 protein or a history of certain serious medical conditions.

Inclusion Criteria

Sign and date the main Informed Consent Form (ICF)

My heart pumps well, with an ejection fraction of 50% or higher.

Measurable disease based on RECIST V1.1

Exclusion Criteria

I have or might have a lung condition not caused by an infection.

Has active human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid viral load and cluster of differentiation 4 count

I have or had cancer spread to my brain or spine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part 1)

Participants receive an intravenous (IV) infusion of DS-3939a to determine the safety and tolerability of the drug

8-12 weeks

Dose Expansion (Part 2)

Multiple expansion cohorts receive DS-3939a to further evaluate efficacy in various advanced solid tumors

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DS-3939a

Trial Overview The trial is testing DS-3939a's safety and effectiveness on patients with advanced solid tumors. It will involve two parts: one for various cancer types without molecular subtype restrictions and another for those who've seen their cancer progress after recent treatment.

Participant Groups

Group I: Dose Expansion (Part 2) Experimental Treatment 1 Intervention

Multiple expansion cohorts targeting various advanced solid tumors.

Group II: Dose Escalation (Part 1) Experimental Treatment 1 Intervention

Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a.

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

Daiichi Sankyo, Inc.

Lead Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University