Actively Recruiting
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
Led by Wuhan YZY Biopharma Co., Ltd. · Updated on 2026-05-14
96
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating M701, a recombinant EpCAM and CD3 bispecific antibody, in patients with malignant pleural effusions caused by non-small cell lung cancer (NSCLC). This phase 1/phase 2 multicenter, open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary effectiveness of M701. The study includes patients whose cancer has progressed after first-line treatment and who have moderate or greater pleural fluid requiring intervention. The study has two phases. Phase 1b includes dose escalation with up to four cohorts followed by a cohort expansion where participants receive M701 injections at different frequencies (3, 4, or 6 injections) to evaluate dosing frequency. Phase 2 uses the dose and schedule determined in Phase 1b to randomly assign participants to receive either M701 plus pleural drainage or a control treatment of cisplatin or pleural effusion suction. Treatments involve pleural drainage guided by ultrasound and pleural infusions of M701 or cisplatin. Participants will undergo safety monitoring for dose-limiting toxicities and adverse events from the first dose through 28 days or until study end. Effectiveness will be measured by response rates of pleural effusion and puncture-free survival over up to 56 days. Additional assessments include blood and pleural fluid analyses for drug levels, immune responses, tumor markers, and pleural symptoms. The trial expects to enroll adults aged 18 to 75 years, with follow-up continuing until disease progression or intolerance.
CONDITIONS
Brief 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 that has progressed after first-line systemic therapy
- Malignant pleural effusion diagnosed by histology or cytology with moderate or above moderate pleural fluid (depth 6 4 cm or volume 6 500 mL) requiring clinical intervention and not treated yet
- Washout period of at least 4 weeks or 5 half-lives from prior therapies, except for new or poorly controlled pleural fluid after at least two cycles of systemic therapy
- Recovery to grade 0-1 of toxic reactions from prior cancer therapy, except alopecia, hyperpigmentation, and certain chronic conditions
- Physical status ECOG score 0-2
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, and kidney function as defined by lab values
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Asymptomatic pleural fluid not requiring intervention, bilateral pleural fluid, or pleural fluid separation unsuitable for chest cavity perfusion
- Symptomatic CNS metastases or recent brain metastases requiring therapy
- Known severe allergy to M701 components or similar drugs
- Contraindications to thoracentesis
- Major surgery within 4 weeks before first dose
- Extensive liver metastases over 70%
- Uncontrolled active infection (grade 6 2)
- Need for long-term hormonal or immunosuppressive therapy except specific controlled conditions
- Severe respiratory disease or combined interstitial pneumonia
- History of severe cardiovascular disease or uncontrolled hypertension
- QTc interval over 480 ms or history of significant ventricular arrhythmias
- History of other malignancies within 3 years except certain low-risk cancers
- Active viral infections including hepatitis B, C, syphilis, or HIV
- Pregnant or breastfeeding women or planning conception within 6 months
- History of neurological or mental disorders including epilepsy or dementia
- Deemed ineligible by the investigator for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive pleural drainage followed by M701 or comparator treatment through pleural infusions or drainage as assigned. The treatment includes multiple infusions over several days depending on the assigned dosing group or control treatment.
4 infusions on Days 1, 4, 7, and 10 with pleural drainage on Day 1
Duration - Up to 56 days after first dosing
Participants are monitored for safety, response to treatment, and pleural effusion outcomes after the treatment period.
Regular visits for assessments up to 8 weeks
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
L
Li Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here