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

Phase 1

Recruiting

• Conditions: Advanced Unresectable Solid Tumors
• Interventions: Drug: M108

• Registration Number: NCT04894825
• Lead Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-20
• Study Start: 2021-06-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27
• Primary Completion: 2024-07-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1. Written informed consent.
2. Advanced Unresectable solid tumors proven by histology
3. At least 1 measurable site of the disease according RECIST 1.1 criteria
4. ECOG performance status (PS) 0-1
5. Life expectancy > 3 months
6. Age ≥ 18 years and ≤75 years
7. 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.
8. 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.
9. Adequate hepatic function; bilirubin ≤1.5 x ULN, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN.
10. Adequate renal function; creatinine ≤1.5 x ULN, or reatinine clearance rate ≥60 mL/minute calculated.

Exclusion Criteria

1. 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;
2. 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).
3. Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
4. Previous major operation within 8 weeks prior to the start of study treatment.
5. Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanised or chimeric antibodies.
6. Symptomatic cerebral metastases.
7. Uncontrolled or severe illness.
8. Known human immunodeficiency virus infection or known symptomatic hepatitis
9. Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Expansion Cohort	M108	Once the effective dose has been determined, 1\~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.
Dose Escalation Cohort	M108	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).

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	21 days	MTD
Incidence of adverse events	From enrollment until 28+7 days after the last dose	defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)

Secondary Outcome Measures

Name	Time	Method
Half-life of M108	From enrollment until 28 days after the last dose	T1/2
Maximum measured plasma concentration of M108	From enrollment until 28 days after the last dose	Cmax
Objective Response Rate	From first dose to disease progression , death or end of study，an average of 1 year	ORR
Time to maximum plasma concentration of M108	From enrollment until 28 days after the last dose	Tmax
Immunogenicity profile of M108	From enrollment until 28 days after the last dose	Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA).
Progression free survival	From first dose to disease progression , death or end of study，an average of 1 year	PFS

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China