Actively Recruiting
A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC
Led by Wuhan YZY Biopharma Co., Ltd. · Updated on 2026-05-14
96
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged over 18 years
- Confirmed non-small cell lung cancer progressed after first-line systemic therapy
- Malignant pleural effusion diagnosed by histology or cytology, with moderate or greater pleural fluid requiring clinical intervention and untreated
- At least 4 weeks or 5 half-lives washout after last systemic therapy (including radiotherapy, chemotherapy, immunotherapy, biological, targeted, hormonal therapy), except for new or poorly controlled pleural fluid after at least 2 cycles of systemic therapy
- Recovery to grade 0-1 of prior antineoplastic therapy toxicities (except alopecia, hyperpigmentation, ≤ grade 2 neuropathy, hormone replacement hypothyroidism, or confirmed chronic adverse events)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy of at least 12 weeks
- Adequate bone marrow function (ANC ≥ 1.5 x10⁹/L, platelets ≥ 100 x10⁹/L, hemoglobin ≥ 8.5 g/dL without recent transfusion)
- Adequate liver function (bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN or ≤ 5 x ULN if liver metastases present)
- Adequate kidney function (serum creatinine ≤ 1.5 x ULN)
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Asymptomatic pleural fluid not needing intervention, bilateral malignant pleural fluid, or pleural fluid separation observed by chest perfusion
- Symptomatic central nervous system metastases requiring treatment; stable brain metastases allowed if asymptomatic for ≥ 4 weeks and no corticosteroid or anticonvulsant therapy needed
- Known severe allergy to M701 components or antibody-like drugs
- Contraindications to thoracentesis
- Major surgery within 4 weeks before first dose
- Extensive liver metastases (>70%)
- Uncontrolled active infection (grade ≥ 2)
- Need for long-term hormonal or immunosuppressive therapy, except controlled type I diabetes, hypothyroidism with replacement, or non-systemic skin diseases
- Severe respiratory disease or combined interstitial pneumonia
- History of severe cardiovascular disease, recent myocardial infarction, unstable angina, congestive heart failure (NYHA III-IV), or uncontrolled hypertension
- QTc interval > 480 ms, history of long or short QT syndrome, ventricular arrhythmias, or defibrillator implantation
- Other malignancies within 3 years except certain low-risk skin, cervical, or breast lesions
- Active hepatitis B or C, active syphilis, or positive HIV antibodies
- Pregnant or breastfeeding women or planning conception within 6 months
- History of neurological or mental disorders including epilepsy or dementia
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
S
ShaoYi Huang
CONTACT
L
Li Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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