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

NCT05543330 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-05-14

No results posted yet for this study

Summary

This 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.

Conditions

  • Malignant Pleural Effusions
  • NSCLC Stage IV

Interventions

DRUG

M701 pleural infusion

M701 pleural infusion on Days 1,4,7 and 10.

PROCEDURE

Pleural drainage

Pleural effusion drainage via Ultra-sound guidance on Day 1.

DRUG

Cisplatin pleural infusion

Cisplatin pleural infusion (30-50mg/m2) on Day 1.

Sponsors & Collaborators

  • Wuhan YZY Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yiping Zhang · Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

  • Zhengbo Song · Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2026-09-15
Completion
2026-12-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543330 on ClinicalTrials.gov