RecruitingPhase 1Phase 2NCT05543330

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

A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of M701, a Recombinant Epcam and CD3 Bispecific Antibody , in Patients With Malignant Pleural Effusions Caused by NSCLC


Sponsor

Wuhan YZY Biopharma Co., Ltd.

Enrollment

96 participants

Start Date

Sep 30, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing M701 — a bispecific antibody that targets both cancer cells and immune cells to help the immune system attack tumors — for patients with non-small cell lung cancer (NSCLC) that has caused a malignant pleural effusion (a build-up of cancer-containing fluid around the lung). This fluid is a sign that the cancer has spread to the lining of the lung, which is very difficult to treat. **You may be eligible if:** - You are 18 years or older - You have been confirmed to have NSCLC that has progressed after at least one prior systemic treatment - You have a moderate-to-large malignant pleural effusion confirmed by imaging and cytology - Your general health is adequate for treatment **You may NOT be eligible if:** - Your cancer has not been previously treated with systemic therapy - You have active autoimmune disease or are on immunosuppressive drugs - You have uncontrolled brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGM701 pleural infusion

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

PROCEDUREPleural drainage

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

DRUGCisplatin pleural infusion

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


Locations(1)

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Hangzhou, Zhejiang, China

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NCT05543330


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