A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWuhan YZY Biopharma Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
M701 pleural infusion
DrugM701 pleural infusion on Days 1,4,7 and 10.
Pleural drainage
Procedure/SurgeryPleural effusion drainage via Ultra-sound guidance on Day 1.
Cisplatin pleural infusion
DrugCisplatin pleural infusion (30-50mg/m2) on Day 1.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 2 interventions
Group B: Control groupSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicities (DLTs)
Dose limiting toxicities during the first 28 days after the first administrations of study drug in each cohort.
Time frame
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.
Time frame
From the start of administration to the end of the study or 28 days after the administration is stopped3
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.
Time frame
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
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.
Time frame
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.
Time frame
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.
Time frame
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
Time frame
From the time of first dosing (Day 1) until disease progression or toxicity intolerance(up to 16 days)Other outcomes
1
Objective Response Rate of Tumor
ORR is defined as percentage of participants who achieved complete response (CR), partial response (PR), based on RESIST 1.1 .
Time frame
From the time of first dosing (Day 1) until disease progression (up to 56 days)2
Disease Control Rate of tumor
ORR is defined as percentage of participants who achieved complete response (CR), partial response (PR), and stable disease (SD), based on RESIST 1.1 .
Time frame
From the time of first dosing (Day 1) until disease progression (up to 56 days)3
Progression-free disease survival (PFS)
PFS was defined as the time between the date of first dose of M701 and either disease progression or death, whichever occurs first.
Time frame
12 months (anticipated)4
Half-year / One-year Survival Rates
Half-year / One-year Survival Rates
Time frame
1 year (anticipated)Sponsors and contacts
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Source ClinicalTrials.gov