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Malignant Pleural EffusionsPhase 1/2NCT05543330

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

A Phase 1/2 study testing M701 pleural infusion, Pleural drainage and Cisplatin pleural infusion in people with Malignant Pleural Effusions and NSCLC Stage IV, run by Wuhan YZY Biopharma Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Pleural Effusions, NSCLC Stage IV
What is being tested?
M701 pleural infusion, Pleural drainage and Cisplatin pleural infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
1 siteChina
Study dates
30 Sep 2022to 15 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 subjects with local malignant pleural effusion progression or inadequately controlled).
  • 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 pleural effusion by B-mode ultrasound in sitting position is ≥ 4 cm, and the actual drainage volume of pleural effusion is ≥ 500 mL), and the study physician judges that clinical intervention is required.
  • 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, pigmentation, and Grade ≤ 2 neuropathy, hypothyroidism on hormone replacement therapy, or other adverse events that are confirmed to be chronic.
  • ECOG score (PS) of 0-1 (for subjects 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 hematopoietic stimulating factors within 14 days before the first dose): absolute neutrophil count (ANC) ≥ 1.5 109/L, platelet (PLT) ≥ 100 109/L, and hemoglobin (HGB) ≥ 85 g/L; Hepatic function: total bilirubin (TBIL) ≤ 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (AST and ALT ≤ 5 × ULN in case of liver metastasis), serum albumin > 28 g/L; Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN.
  • 9.Understand and voluntarily sign the written informed consent form.

Who cannot join

  • Subjects with recurrent pleural effusion within 4 weeks after the last intrathoracic perfusion treatment and requiring clinical intervention.
  • Subjects who have received intrathoracic infusion of immune drugs, such as PD-1, PD-L1, CTLA-4, and other immune checkpoint inhibitors (excluding interleukins).
  • Subjects 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 effusion), or complicated with chylothorax, or with moderate or greater pericardial effusion, or pneumothorax.
  • Subjects 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 have stable disease as indicated by imaging examination ≥ 4 weeks before the first dose and do not require corticosteroids or anticonvulsant therapy.
  • Subjects with known history of severe allergy to any ingredient of M701 or similar macromolecular antibody drugs.
  • Subjects with contraindications to thoracentesis.
Show all 17Show fewer
  • Subjects who have undergone major surgery within 4 weeks before the first dose.
  • Subjects combined with active infection that have not been controlled to a clinically stable state within the previous 3 days before randomization.
  • Subjects 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 screened: type I diabetes; hypothyroidism that can be controlled by replacement therapy only; skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
  • Subjects 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, angina pectoris unstable, hemorrhage brain, etc.) or pulmonary embolism within the past 6 months, or received a vascular stent implantation (such as coronary artery stent implantation, intracranial artery stent implantation, etc.) within the past 6 months; or experienced a new venous thrombotic disease such as lower extremity venous thrombosis has occurred within the past 1 month.
  • 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 examination should be retested to obtain the mean corrected value of 3 retests); family or personal history of long or short QT syndrome; clinically significant history of arrhythmia, or implantation of defibrillation device for ventricular arrhythmia.
  • 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 breast, or other non-invasive diseases that are considered by the investigator and the sponsor to be cured with minimal risk of recurrence within 3 years).
  • 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 hepatitis C (hepatitis C antibody-positive, and [e.g., hepatitis C virus (HCV-RNA) higher than the analytical method] antibody-positive, with HCV-RNA ≥ the lower limit of detection), [,] human immunodeficiency virus (HIV) antibody-positive or active syphilis, HIV antibody-positive infection (syphilis-specific antibody-positive and syphilis non-specific antibody-positive);
  • Pregnant or lactating women; men or women who plan to have children within 6 months after the end of this clinical study.
  • Subjects 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ShaoYi Huang contact

86-027-82668440

huangshaoyi@yzybio.com

Li Huang contact

13647219857

huangli@yzybio.com

China1 site, 1 recruiting

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

    Hangzhou, Zhejiang, 310022

    Weizhen Xu, zjchgcp@163.com, zjchgcp@163.com

    Zhengbo Song, 0571-88122168, songzb@zjcc.org.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This study is consisted of two phase, Phase Ib and II:

Phase 1b includes dose escalation phase and cohort expansion phase. In dose escalation phase, up to 4 dose-escalation cohorts will be sequentially enrolled with regular "3+3" design. DLTs will be evaluated during the first treatment cycle, which is 28 days. In cohort expansion phase, after the RP2D was identified, participants were enrolled in an open-ended manner. Participants were assigned to groups A(3 injections), B (4 injections)and C(6 injections) on a 1:1:1 basis to evaluate the dose frequency.

Phase II:The dose and dosing frequency of M701 drug for the Phase II clinical trial were determined based on a combination of the tolerance1 and efficacy of M701 in the Phase Ib trial. Then the participants were randomly divided into two groups: the test group(M701) and the control group(cisplatin or pleural effusions suctions). The pleural effusions response (ORR) and Puncture Free Survival （PuFS）will be evaluated.

Being tested
M701 pleural infusion, Pleural drainage, Cisplatin pleural infusion
Keywords
Malignant Pleural Effusions, NSCLC
Medical subject headings
Pleural Effusion, Malignant, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M701 pleural infusionDrug

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

  • Pleural drainageProcedure or surgery

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

  • Cisplatin pleural infusionDrug

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

Study groups in NCT05543330
Study groupRoleWhat they receive
Experimental groupExperimentalPleural drainage and M701 infusion
Receives: Drug: M701 pleural infusion; Procedure: Pleural drainage
Control groupSham comparatorPleural drainage only or plus chemotherapy as investigator's choice.
Receives: Procedure: Pleural drainage; Drug: Cisplatin pleural infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLTs)

    Dose limiting toxicities during the first 28 days after the first administrations of study drug in each cohort.

    Measured: From the time of the first dose (Day 1) until the forth dosing (Day 28)

  2. Incidence of AEs

    Incidence and severity of AEs, including but not limited to vital signs, physical examination, laboratory tests. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.

    Measured: From the start of administration to the end of the study or 28 days after the administration is stopped

  3. Puncture-free survival (PuFS)

    The time from removing the thoracic drainage tube after last intrapleural infusion to the time when re-drainage is required (based on the time when puncture and drainage occur) or death, whichever occurs first.

    Measured: The time from removing the thoracic drainage tube after last intrapleural infusion to the time when re-drainage is required or death, assessed up to 12 months after enrollment or randomization.

Secondary outcomes (15)

  1. Area under the curve (AUC) of M701

    The endpoints for assessment of PK of M701 include serum concentrations of M701 at different timepoints after M701 administration.

    Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance(up to 16 days)

  2. Maximum observed concentration (Cmax) of M701

    The endpoints for assessment of PK of M701 include serum concentrations of M701 at different timepoints after M701 administration.

    Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance(up to 16 days)

  3. Minimum observed concentration (Cmin) of M701

    The endpoints for assessment of PK of M701 include serum concentrations of M701 at different timepoints after M701 administration.

    Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance(up to 16 days)

  4. Half-time (t1/2) of M701

    Half-time (t1/2) of M701

    Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance(up to 16 days)

  5. Anti-drug antibodies(ADAs) titer

    The immunogenicity of M701 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

    Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance(up to 16 days)

  6. Neutralizing antibody titer

    The immunogenicity of M701 will be collected by testing the antibody titer of the neutralizing antibody.

    Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance(up to 16 days)

  7. Concentrations of tumor biomarker in pleural effusions

    As tumor biomarkers, concentrations of CEA, CyFra21-1, SCC and NSE in malignant pleural effusions will be examined at Day 1 and Day10.

    Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance(up to 56 days)

  8. Expression level of EpCAM-positive cells in pleural effusions

    The number and expression levels of EpCAM-positive cells in pleural effusions will be measured by pathological methods (including cytospin, immunohistochemical techniques, etc.)

    Measured: From the time of first dosing (Day 1) until disease progression (up to 56 days)

  9. Ratio of EpCAM-positive tumour cell/leucocyte

    Ratio of EpCAM positive tumour cell/leucocyte in pleural effusions will be measured by FACS method.

    Measured: From the time of first dosing (Day 1) until disease progression (up to 56 days)

  10. Rate of with successful pleurodesis (4/8 weeks)

    the rate of patients with successful pleurodesis at 4 weeks / 8 weeks

    Measured: From the time of first dosing (Day 1) until disease progression (up to 56 days)

  11. Puncture-free survival rate at 8 and 14 weeks after the first intrapleural dose.

    Puncture-free survival rate at 8 and 14 weeks after the first intrapleural dose.

    Measured: 8 weeks and 14 weeks following the first dose .

  12. Pleural signs and symptoms

    Using the Lister Quadruple Scale to record pleural effusions at 4 weeks/ 8 weeks.

    Measured: From the time of first dosing (Day 1) until disease progression (up to 56 days)

  13. Puncture-free survival (PuFS)

    The time from removing the thoracic drainage tube after last intrapleural infusion to the time when re-drainage is required (based on the time when puncture and drainage occur) or death, whichever occurs first.

    Measured: The time from removing the thoracic drainage tube after last intrapleural infusion to the time when re-drainage is required or death, assessed up to 12 months after enrollment or randomization.

  14. Time to Next Puncture (TTNP)

    Defined to be the period from the end of the treatment (based on the time when the thoracic drainage tube is removed, the same as the starting time point of PuFS) to the time when the subject requires another thoracic puncture for drainage.

    Measured: The time from removing the thoracic drainage tube after last intrapleural infusion to the time when re-drainage is required, assessed up to 12 months after enrollment or randomization.

  15. Quality of life score

    Evaluated according to the EORTC quality of life scale QLQ-C30 (V3.0) and scale QLQ-LC13 (see Appendix 3 for details)

    Measured: From Day 1 (enrollment or randomization) to the end of the study , up to 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start30 Sep 2022
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
For Phase 2 study, the patients are enrolled into 2 arm parallelly.
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05543330
Sponsor's protocol ID
M70103
Status last verified
Jul 2026
First submitted
14 Sep 2022
Last updated
8 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing M701 pleural infusion, Pleural drainage and Cisplatin pleural infusion in people with Malignant Pleural Effusions and NSCLC Stage IV, run by Wuhan YZY Biopharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ShaoYi Huang (86-027-82668440, huangshaoyi@yzybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLTs) (time frame: From the time of the first dose (Day 1) until the forth dosing (Day 28)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05543330.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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