DS-2243a for Solid Tumors

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Daiichi Sankyo

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CNS metastases, Cardiovascular disease, Autoimmune, others

No Placebo Group

Trial Summary

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.

Research Team

Eligibility Criteria

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.

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Trial Timeline

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

Treatment Details

Interventions

DS-2243a (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion UCExperimental Treatment1 Intervention

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

Group II: Part 2: Dose Expansion Sq-NSCLCExperimental Treatment1 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/MRCLSExperimental Treatment1 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-NSCLCExperimental Treatment1 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-2243aExperimental Treatment1 Intervention

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