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

F

FutureGen Biopharmaceutical

Status and phase

Enrolling
Phase 1

Conditions

Advanced Unresectable Solid Tumors

Treatments

Drug: M108

Study type

Interventional

Funder types

Industry

Identifiers

NCT04894825
M108-Ⅰ

Details and patient eligibility

About

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.

Enrollment

152 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

152 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Zhaoyu Jin, Ph.D

Data sourced from clinicaltrials.gov

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