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