Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China

NCT04894825 | Unknown Phase 1

• 1 other identifier: M108-Ⅰ
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable Solid Tumors in China.

Conditions

Advanced Unresectable Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)

  From enrollment until 28+7 days after the last dose

• Maximum Tolerated Dose

  MTD

  21 days

Secondary Outcomes (6)

• Maximum measured plasma concentration of M108

  From enrollment until 28 days after the last dose

• Time to maximum plasma concentration of M108

  From enrollment until 28 days after the last dose

• Half-life of M108

  From enrollment until 28 days after the last dose

• Immunogenicity profile of M108

  From enrollment until 28 days after the last dose

• Objective Response Rate

  From first dose to disease progression , death or end of study，an average of 1 year

Study Arms (2)

Dose Escalation Cohort

EXPERIMENTAL

Monotherapy: Five dose levels of M108 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Combined with chemotherapy: Three dose levels of M108 will be tested by a conventional 3 + 3 study design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (21 days).

Drug: M108

Dose Expansion Cohort

EXPERIMENTAL

Once the effective dose has been determined, 1\~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.

Drug: M108

Interventions

M108 DRUG

Monotherapy: Accelerated titration method, IV infusion Q3W; Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles)

Also known as: Chemotherapy

Dose Escalation Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Advanced Unresectable solid tumors proven by histology
• At least 1 measurable site of the disease according RECIST 1.1 criteria
• ECOG performance status (PS) 0-1
• Life expectancy \> 3 months
• Age ≥ 18 years and ≤75 years
• Adequate haematological function; absolute neutrophil count ≥1.5 x 109/L; white blood cell count ≥3.0 x 109/L; platelets ≥100 x 109/L; haemoglobin ≥9 g/dL.
• Adequate coagulation function; international normalized ratio ( INR) ≤ 1.5 x upper limit of normal (ULN), or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
• Adequate hepatic function; bilirubin ≤1.5 x ULN, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN.
• Adequate renal function; creatinine ≤1.5 x ULN, or reatinine clearance rate ≥60 mL/minute calculated.

You may not qualify if:

• Previous received or planned to be vaccinated with 2019-nCoV vaccine or other vaccines within 3 months prior to the start of study treatment or during the study or within 3 months after the end of the study;
• Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastatic side peripherally and the patient recovered from acute toxicity was allowed).
• Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
• Previous major operation within 8 weeks prior to the start of study treatment.
• Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanised or chimeric antibodies.
• Symptomatic cerebral metastases.
• Uncontrolled or severe illness.
• Known human immunodeficiency virus infection or known symptomatic hepatitis
• Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study

Sponsors & Collaborators

• FutureGen Biopharmaceutical (Beijing) Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Zhaoyu Jin, Ph.D

CONTACT

010-60709130; pr@futuregenbiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 20, 2021
• Study Start: June 11, 2021
• Primary Completion: July 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

CN (1)