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RecruitingNCT04894825Updated Nov 27, 2023

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

A Phase 1 interventional study of M108 and M108 in Advanced Unresectable Solid Tumors, sponsored by FutureGen Biopharmaceutical (Beijing) Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by FutureGen Biopharmaceutical (Beijing) Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
152
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Unresectable Solid Tumors

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03

In context

Neoplasms

9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.

This study's planned enrollment of 152 is above the median of 50 across 7,258 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

FutureGen Biopharmaceutical (Beijing) Co., Ltd is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    Dose Escalation Cohort

    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

  • Experimental
    Dose Expansion Cohort

    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

  • DrugM108

    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

  • DrugM108

    IV infusion Q3W. (21-day cycles)

    Also known as: Chemotherapy.

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events

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

    Time frame: From enrollment until 28+7 days after the last dose

  2. Maximum Tolerated Dose

    MTD

    Time frame: 21 days

Secondary outcomes

  1. Maximum measured plasma concentration of M108

    Cmax

    Time frame: From enrollment until 28 days after the last dose

  2. Time to maximum plasma concentration of M108

    Tmax

    Time frame: From enrollment until 28 days after the last dose

  3. Half-life of M108

    T1/2

    Time frame: From enrollment until 28 days after the last dose

  4. Immunogenicity profile of M108

    Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA).

    Time frame: From enrollment until 28 days after the last dose

  5. Objective Response Rate

    ORR

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

  6. Progression free survival

    PFS

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

07

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04894825
Lead sponsor
FutureGen Biopharmaceutical (Beijing) Co., Ltd
Responsible party
Sponsor
First posted
May 20, 2021
Start date
Jun 11, 2021
Primary completion
Jul 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Nov 27, 2023

Study contacts

Zhaoyu Jin, Ph.D
Contact
pr@futuregenbiopharm.com
010-60709130

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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