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Monoclonal Antibodies

DS-2243a for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

9. Participants with NSCLC or UC: NY-ESO protein expression in tumor tissue is tested and confirmed by an IHC assay in a central laboratory.

8. Has ECOG PS score of 0 or 1 at Screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if DS-2243a is safe and effective in treating people with advanced solid tumors.

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

As this is a first-in-human trial for DS-2243a, side effects are currently unknown but will be closely monitored throughout the study to ensure participant safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I have a specific HLA-A*02 gene type.

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My cancer is advanced and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 2: Number of participants with Treatment-Emergent Adverse Events

Part 2: Objective Response Rate

Secondary study objectives

Disease Control Rate

Part 1: Objective Response Rate

Progression-Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met