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OncoMatch/Clinical Trials/NCT07304128

A Study of PLB-002 in Advanced Solid Tumors

Is NCT07304128 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PLB-002 for advanced solid tumor.

Phase 1RecruitingPrimelink BioTherapeitics(ShenZhen) LimitedNCT07304128Data as of May 2026

Treatment: PLB-002This study will test the safety, including side effects, and determine the characteristics of a drug called PLB-002 in participants with solid tumors.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Biomarker criteria

Required: CLDN6 positive staining by immunohistochemistry

Part 2: Positive CLDN6 staining of tumor tissue (archived or fresh) by IHC tested in the central laboratory

Disease stage

Metastatic disease required

At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard-of-care therapy

who have failed or intolerant to available standard-of-care therapy or no standard treatment exists

Cannot have received: systemic chemotherapy

Patient received systemic chemotherapy...within 2 weeks prior to start of study drug

Cannot have received: small molecular target therapy

Patient received...small molecular target therapy...within 2 weeks prior to start of study drug

Cannot have received: hormone therapy

Patient received...hormone therapy...within 2 weeks prior to start of study drug

Cannot have received: herbal medication with anti-cancer indication

Patient received...herbal medication with anti-cancer indication within 2 weeks prior to start of study drug

Cannot have received: biological anti-cancer products (such as antibody, antibody-drug conjugate [ADC])

received biological anti-cancer products (such as antibody, antibody-drug conjugate [ADC]) within 4 weeks or 5 half-life time prior to start of study drug (whichever is shorter)

Cannot have received: cytotoxic agents with major delayed toxicity (such as nitrosourea or mitomycin C) (nitrosourea, mitomycin C)

For cytotoxic agents with major delayed toxicity (such as nitrosourea or mitomycin C), 6 weeks of washout are mandated

Cannot have received: anti-cancer therapies targeting at CLDN6

Patient has received any other anti-cancer therapies targeting at CLDN6

Lab requirements

Blood counts

Neutrophils ≥ 1.5 × 10^9/L; Platelets ≥ 100× 10^9/L; Hemoglobin ≥ 90 g/L (no transfusion or hematopoietic stimulating factor treatment within 14 days)

Kidney function

Creatinine clearance (Ccr) ≥ 60 mL/min (Ccr calculated according to Cockcroft-Gault formula)

Liver function

Total bilirubin ≤ 1.5×ULN (≤ 3.0×ULN for patients with Gilbert's syndrome or liver metastasis/hepatocellular carcinoma); ALT ≤ 2.5×ULN (≤ 5.0×ULN for patients with liver metastasis/hepatocellular carcinoma); AST ≤ 2.5×ULN (≤ 5.0×ULN for patients with liver metastasis/hepatocellular carcinoma); Albumin ≥ 3.0 g/dL

Cardiac function

Left ventricular ejection fraction (LVEF) ≥ 50%

Have adequate organ function, as indicated by the following laboratory parameters in below table. Hematologic...Hepatic function...Renal function...Coagulation function...Cardiac function...

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

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