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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• Patients who had recovered to grade 0-1 of any toxic reaction to prior antineoplastic therapy as determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0, with the exception of alopecia, hyperpigmentation and ≤ grade 2 neuropathy, hormone replacement hypothyroidism or other adverse events confirmed to have turned chronic.

• Patients with physical status ECOG score (PS) of 0-2.

• Patients with life expectancy ≥ 12 weeks.

• Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 ×10\^9/L, platelet count ≥ 100 ×10\^9/L, hemoglobin ≥ 8.5 g/dL (without blood transfusion within14 days of the first dose of study drug); Liver: bilirubin (TBIL)≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 x ULN ( ≤ 5 x ULN in case of liver metastases); Kidney: serum creatinine ≤1.5 x ULN.

• Patients must understand and voluntarily sign the written informed consent.

Locations
Other Locations
China
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
RECRUITING
Hangzhou
Contact Information
Primary
ShaoYi Huang
huangshaoyi@yzybio.com
86-027-82668440
Backup
Li Huang
huangli@yzybio.com
13647219857
Time Frame
Start Date: 2022-09-30
Estimated Completion Date: 2026-10-15
Participants
Target number of participants: 96
Treatments
Experimental: Experimental group
Pleural drainage and M701 infusion
Sham_comparator: Control group
Pleural drainage only or plus chemotherapy as investigator's choice.
Related Therapeutic Areas
Sponsors
Leads: Wuhan YZY Biopharma Co., Ltd.

This content was sourced from clinicaltrials.gov

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