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New treatment option for Malignant Pleural Effusions
Official title A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC
ClinicalTrials.gov ID: NCT05543330
What this study is testing
What is M701 pleural infusion?
M701 pleural infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant pleural effusions.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged \>18 years and ≤ 75 years, male or female.
- Histologically or cytologically confirmed advanced non-small cell lung cancer that has progressed after at least one line of systemic anti-tumor...
- Malignant pleural effusion requiring intrathoracic perfusion treatment (malignant pleural effusion should be diagnosed histologically or...
- If the subject received latest systemic treatment regimen at least 1 course (at least 21 days for targeted therapy) and poorly controlled pleural...
- Any toxicity from prior antineoplastic therapy should have recovered to Grade 0-1 as determined by National Cancer Institute Common Terminology...
You likely can't join if
- people with recurrent pleural effusion within 4 weeks after the last intrathoracic perfusion treatment and requiring clinical intervention.
- people who have received intrathoracic infusion of immune drugs, such as PD-1, PD-L1, CTLA-4, and other immune checkpoint inhibitors (excluding...
- people with malignant pleural effusion requiring clinical intervention on both sides, or those in whom adequate drainage of pleural effusion is not...
- people with central nervous system (CNS) metastases resulting in clinical symptoms or requiring therapeutic intervention; patients with previously...
- people with known history of severe allergy to any ingredient of M701 or similar macromolecular antibody drugs.
- people with contraindications to thoracentesis.
See the full eligibility criteria
- Aged \>18 years and ≤ 75 years, male or female.
- Histologically or cytologically confirmed advanced non-small cell lung cancer that has progressed after at least one line of systemic anti-tumor treatment (including people with local malignant pleural effusion...
- Malignant pleural effusion requiring intrathoracic perfusion treatment (malignant pleural effusion should be diagnosed histologically or cytologically), with moderate or above amount of pleural effusion (the depth of...
- If the subject received latest systemic treatment regimen at least 1 course (at least 21 days for targeted therapy) and poorly controlled pleural effusion , then no washout interval is required.
- Any toxicity from prior antineoplastic therapy should have recovered to Grade 0-1 as determined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0, except alopecia...
- ECOG score (PS) of 0-1 (for people with inadequately controlled malignant pleural effusion of whom ECOG score is 2 can be enrolled).
- An expected survival ≥ 12 weeks. 8.8.Organ functions must meet the following criteria: Hemogram (no transfusion of blood or blood products, no correction with granulocyte-colony stimulating factor (G-CSF) or other...
- people with recurrent pleural effusion within 4 weeks after the last intrathoracic perfusion treatment and requiring clinical intervention.
- people who have received intrathoracic infusion of immune drugs, such as PD-1, PD-L1, CTLA-4, and other immune checkpoint inhibitors (excluding interleukins).
- people with malignant pleural effusion requiring clinical intervention on both sides, or those in whom adequate drainage of pleural effusion is not possible due to objective reasons (including loculated pleural...
- people with central nervous system (CNS) metastases resulting in clinical symptoms or requiring therapeutic intervention; patients with previously treated brain metastases can be enrolled if they are asymptomatic and...
- people with known history of severe allergy to any ingredient of M701 or similar macromolecular antibody drugs.
- people with contraindications to thoracentesis.
- people who have undergone major surgery within 4 weeks before the first dose.
- people combined with active infection that have not been controlled to a clinically stable state within the previous 3 days before randomization.
- people who require long-term hormone or immunosuppressive therapy, such as active autoimmune diseases, maintenance therapy after organ transplantation, but patients with the following conditions are allowed to be...
- people with severe respiratory diseases or interstitial pneumonia, who are not suitable for enrollment as determined by the investigator.
- Combined with severe cardiovascular disease, including cardiac insufficiency (New York Heart Association class III-IV), or acute cardiovascular event (such as acute myocardial infarction, acute cerebral infarction...
- The mean corrected QT interval (QTcF) \> 450 ms (male) or \> 470 ms (female) in 3 electrocardiogram (ECG) examinations at screening (only those with QTcF \> 450 ms (male) or \> 470 ms (female) at the first ECG...
- History of malignancy (other than the study tumor) within 3 years prior to the date of first dose of investigational drug (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix or...
- Combined with active chronic hepatitis B (e.g., hepatitis B surface antigen [HBsAg]-positive and/or hepatitis B core antibody (HBcAb)-positive, with HBV-DNA quantification ≥1×10⁴ copies/mL or ≥2000 IU/mL), active...
- Pregnant or lactating women; men or women who plan to have children within 6 months after the end of this clinical study.
- people with a history of confirmed neurological or mental disorders who cannot cooperate with the treatment and follow the doctor's advice as judged by the investigator.
- Other conditions that the investigator considers unsuitable for participating in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.