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
Males or females, aged > 18 years.
Histologically- or cytologically-confirmed non-small cell lung cancer that has progressed after first line systemic therapy.
Malignant pleural effusion diagnosed histologically or cytologically, with moderate or above moderate pleural fluid (sitting pleural fluid depth ≥ 4 cm via ultrasound, expected pleural fluid volume ≥ 500 mL) . Require clinical intervention and not treated yet.
Patients who have an washout period of ≥ 4 weeks or 5 half-life of the drug (including radiotherapy, chemotherapy, immunotherapy, biologic, targeted, hormonal therapy, and 14 days for local radiotherapy) between the last systemic therapy and the first dose; however, no washout period is required if the subject has new pleural fluid or poor control of current pleural fluid after at least 2 cycle systemic therapy.
Disqualifiers
Patients with asymptomatic pleural fluid and not requiring clinical intervention, or bilateral malignant pleural fluid, or proposed perfusion of the chest cavity presenting with pleural fluid separation.
Patients with central nervous system (CNS) metastases resulting in clinical symptoms or requiring therapeutic intervention; patients previously treated for brain metastases may be enrolled if they have been asymptomatic for ≥ 4 weeks prior to the first dose and have imaging indicating stable disease and do not require corticosteroid or anticonvulsant therapy.
Patients with a known history of severe allergy to M701 drug components or antibody-like macromolecular drugs.
Patients with contraindications to thoracentesis.
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
96 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
Objective Response Rate(4 weeks/8 weeks) of pleural effusion
the rate of patients with pleural effusion CR and PR at 4 weeks / 8 weeks, based on CT evaluation .
Time frame
From the time of first dosing (Day 1) until disease progression(up to 56 days)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
Duration of disease control(DDC)
Duration of disease control(DDC) was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, based on RESIST 1.1 .
Time frame
12 months (anticipated)4
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)Sponsors and contacts
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Source ClinicalTrials.gov