DS-2243a for Solid Tumors

Recruiting at 3 trial locations

Overseen By Contact for Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Daiichi Sankyo

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CNS metastases, Cardiovascular disease, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for previous treatments: less than 4 weeks for radiation therapy, less than 3 weeks for chemotherapy, antibody-based anticancer therapy, or immunotherapy, and less than 2 weeks or 5 half-lives for small molecules, whichever is longer. If you are on chronic steroid treatment or other immunosuppressive medication, you may need to stop or adjust your dosage.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain advanced solid tumors, including specific types of lymphoma, sarcoma, and lung or urinary cancer that have not responded to standard treatments. Participants must be able to provide a tissue sample and have an acceptable level of physical function (ECOG PS score of 0 or 1).

Inclusion Criteria

My cancer can be measured on scans.

I can provide a sample of my tumor tissue.

My NSCLC or UC tumor tests positive for NY-ESO protein.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive DS-2243a at escalating doses to determine the recommended dose for expansion

Up to 3 years

Dose Expansion

Participants receive DS-2243a at the recommended dose for expansion in various cancer types

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• DS-2243a

Trial Overview The study is testing DS-2243a's safety and effectiveness in treating advanced solid tumors. It has two parts: first, finding the right dose (dose escalation), then seeing how well it works at that dose.

How Is the Trial Designed?

Group I: Part 2: Dose Expansion UC Experimental Treatment 1 Intervention

Participants with urothelial carcinoma will receive DS-2243a at the recommended dose for expansion (RDE)

Group II: Part 2: Dose Expansion Sq-NSCLC Experimental Treatment 1 Intervention

Participants with squamous cell carcinoma-non-small cell lung cancer will receive DS-2243a at the recommended dose for expansion (RDE)

Group III: Part 2: Dose Expansion SS/MRCLS Experimental Treatment 1 Intervention

Participants with synovial sarcoma or myxoid/round cell liposarcoma will receive DS-2243a at the recommended dose for expansion (RDE)

Group IV: Part 2: Dose Expansion Ad-NSCLC Experimental Treatment 1 Intervention

Participants with adenocarcinoma-non-small cell lung cancer will receive DS-2243a at the recommended dose for expansion (RDE)

Group V: Part 1: Dose Escalation DS-2243a Experimental Treatment 1 Intervention

Participants will receive DS-2243a at escalating doses. The recommended dose for expansion (RDE) will be calculated using data collected from this population.

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