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OncoMatch/Clinical Trials/NCT05639153

A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors

Is NCT05639153 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies DR30303 for malignant neoplasm of digestive system.

Phase 1RecruitingZhejiang Doer Biologics Co., Ltd.NCT05639153Data as of May 2026

Treatment: DR30303This study is an open-label Phase 1, First in Human trial of DR30303, a recombinant humanized monoclonal antibody that targets Claudin18.2 (CLDN18.2). It is composed of humanized variable domain of heavy chain of antibody (VHH) fused with engineered immunoglobulin gamma-1(IgG1) Fc. It is being testing against advanced and/or metastatic solid tumors.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Biomarker criteria

Required: CLDN18 positive (positive)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic therapy

failed or were intolerant to at least 1 line of systemic therapy

Cannot have received: treatments targeting Claudin18.2

Ever received any treatments targeting Claudin18.2

Cannot have received: radical radiotherapy

Radical radiotherapy was performed within 12 weeks before the first dose of study drug

Cannot have received: systemic anti-tumor therapy

Subjects who have received other systemic anti-tumor therapy within 4 weeks before the first dose of study drug

Lab requirements

Blood counts

Kidney function

Liver function

Adequate organ function

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

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