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OncoMatch/Clinical Trials/NCT06644755

First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors

Is NCT06644755 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies DS-2243a for solid tumors.

Phase 1RecruitingDaiichi SankyoNCT06644755Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Sarcoma

Biomarker criteria

Required: HLA-A positive for HLA-A*02:01, 02:02, 02:03, 02:04, 02:05, 02:06, 02:09, 02:10, or 02:11

HLA-A*02:01, 02:02, 02:03, 02:04, 02:05, 02:06, 02:09, 02:10, or 02:11 positive

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: appropriate therapies (e.g., standard of care therapy)

Relapsed from, refractory to, or intolerant to appropriate therapies [eg, standard of care (SOC) therapy] to provide clinical benefit for their condition as assessed by their physician and/or investigator.

Cannot have received: NY-ESO-1-targeted therapy

Has received prior therapy targeting NY-ESO-1.

Lab requirements

Blood counts

ANC ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L; Hemoglobin ≥8 g/dL

Kidney function

Creatinine clearance (CrCl) ≥45 mL/min as calculated using the Cockcroft-Gault equation

Liver function

ALT and AST ≤3 × ULN in participants with no liver metastasis, or ≤5 × ULN in participants with liver metastasis; Total bilirubin ≤1.5 × ULN (≤3 × ULN for participants with Gilbert's syndrome)

Meets the following required baseline local laboratory data within 14 days prior to start of trial intervention administration: ALT and AST ≤3 × ULN in participants with no liver metastasis, or ≤5 × ULN in participants with liver metastasis; Total bilirubin ≤1.5 × ULN (≤3 × ULN for participants with Gilbert's syndrome); ANC ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L; Hemoglobin ≥8 g/dL; Creatinine clearance (CrCl) ≥45 mL/min as calculated using the Cockcroft-Gault equation

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Dana-Farber Cancer Institute · Boston, Massachusetts
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center · New York, New York
  • Sarah Cannon Research Institute · Nashville, Tennessee

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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