DS-3939a for Advanced Solid Tumors

Recruiting at 34 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

540 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called DS-3939a to determine its safety and effectiveness for people with advanced solid tumors. It consists of two parts: first, identifying the right dose, and then expanding to treat various tumor types. The study seeks participants with locally advanced, metastatic, or inoperable tumors, particularly if the disease has progressed despite previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that DS-3939a is likely to be safe for humans?

Research has shown that DS-3939a appears safe based on early trials. In one study, 64 patients with advanced solid tumors received varying doses of the treatment. The results indicated that DS-3939a was generally well-tolerated. Some patients experienced mild to moderate side effects, which is common with these treatments. Serious side effects did not pose a major issue, suggesting that DS-3939a could be a safe option for people with advanced solid tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about DS-3939a because it offers a new approach to treating advanced solid tumors. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, DS-3939a is designed to specifically target cancer cells, potentially reducing damage to healthy cells and leading to fewer side effects. This targeted therapy is administered intravenously, allowing precise delivery directly into the bloodstream, which may enhance its effectiveness against tumors that are difficult to treat with existing options. These features could make DS-3939a a promising alternative for patients with limited treatment choices.

What evidence suggests that DS-3939a might be an effective treatment for advanced solid tumors?

Research has shown that DS-3939a has potential in treating advanced solid tumors. In early trials, 64 patients with these tumors experienced some positive effects from the treatment. This suggests that DS-3939a might help slow or stop tumor growth. The treatment targets specific parts of the tumor cells, which could prevent them from spreading. Although more research is needed to confirm these results, the initial findings are promising for people with advanced solid tumors. Participants in this trial will receive DS-3939a in either a dose escalation phase or a dose expansion phase, targeting various advanced solid tumors. ^{1 2 3 4 6}

Who Is on the Research Team?

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Are You a Good Fit for This Trial?

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)

Measurable disease based on RECIST V1.1

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. daiichisankyo.us daiichisankyo.us/press-releases/-/article/ds-3939-shows-promising-preliminary-clinical-activity-in-patients-with-advanced-solid-tumors-in-phase-1-2-trial

DS-3939 Shows Promising Preliminary Clinical Activity in ... Preliminary safety and efficacy results of DS-3939 were reported from the dose escalation part of the phase 1/2 trial in 64 patients with ...

2. daiichisankyo.com daiichisankyo.com/files/news/pressrelease/pdf/202510/20251019_E3.pdf

Press Release - DS-3939 Shows Promising Preliminary ... Preliminary safety and efficacy results of DS-3939 were reported from the dose escalation part of the phase. 1/2 trial in 64 patients with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05875168?term=DS-3939a&rank=1

First-in-Human Study of DS-3939a in Participants With ... This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors. Detailed Description. DS-3939a is an ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS3165

A phase 1/2, first-in-human study of DS-3939a in patients ... This study will assess the safety, tolerability, and efficacy of DS-3939a in patients with advanced solid tumors. Methods: This phase 1/2 ...

5. datasourcebydaiichisankyo.com datasourcebydaiichisankyo.com/documents/20833/21552/AACR%202024_DS-3939_Yamamoto_Poster_FINAL.pdf

A phase 1/2, first-in-human study of DS-3939a in patients ... documented locally advanced, metastatic, or unresectable solid tumors and documented radiographic disease progression coinciding with or following their.

6. clinicaltrials.eu clinicaltrials.eu/inn/ds-3939a/

Ds-3939A – Application in Therapy and Current Clinical ... The trial is designed to evaluate how safe DS-3939a is, how well patients tolerate it, and how effective it is in treating advanced solid tumors. Safety and ...