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OncoMatch/Clinical Trials/NCT05543330

A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC

Is NCT05543330 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including M701 pleural infusion and Cisplatin pleural infusion for malignant pleural effusions.

Phase 1/2RecruitingWuhan YZY Biopharma Co., Ltd.NCT05543330Data as of Jun 2026Location: China

Treatment: M701 pleural infusion · Cisplatin pleural infusionThis is a phase 1/phase 2, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of M701 in patients with treatment of malignant pleural effusions caused by NSCLC.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Cisplatin pleural infusion

Other

M701 pleural infusion

Cancer type

Non-Small Cell Lung Carcinoma

Disease stage

Required: Stage IV

Metastatic disease required

NSCLC Stage IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 75

Prior therapy

Min 1 prior line

Lab requirements

Blood counts

ANC ≥ 1.5 ×10^9/L, platelet count ≥ 100 ×10^9/L, hemoglobin ≥ 8.5 g/dL (without blood transfusion within 14 days of the first dose of study drug)

Kidney function

serum creatinine ≤ 1.5 x ULN

Liver function

bilirubin (TBIL) ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastases)

Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 ×10^9/L, platelet count ≥ 100 ×10^9/L, hemoglobin ≥ 8.5 g/dL (without blood transfusion within14 days of the first dose of study drug); Liver: bilirubin (TBIL)≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 x ULN ( ≤ 5 x ULN in case of liver metastases); Kidney: serum creatinine ≤1.5 x ULN.

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

Frequently asked questions

Is NCT05543330 currently recruiting?

Yes, this trial is currently recruiting patients.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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