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

Advanced Unresectable Solid Tumors Clinical Trial

Official title:

A Phase I, Multi-center, Open-label, Single-dose Escalation and Expansion, Dose Escalation and Expansion Combination With Chemotherapy Study Evaluating the Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04894825
• Other study ID #: M108-?
• Status: Recruiting
• Phase: Phase 1
• Start date: June 11, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: FutureGen Biopharmaceutical (Beijing) Co., Ltd
• Contact: Zhaoyu Jin, Ph.D
• Phone: 010-60709130
• Email: pr[@]futuregenbiopharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: December 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Unresectable Solid Tumors
• Neoplasms

Intervention

Drug:
• M108
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)
• M108
IV infusion Q3W. (21-day cycles)

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
FutureGen Biopharmaceutical (Beijing) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Tolerated Dose	MTD	21 days
Secondary	Maximum measured plasma concentration of M108	Cmax	From enrollment until 28 days after the last dose
Secondary	Time to maximum plasma concentration of M108	Tmax	From enrollment until 28 days after the last dose
Secondary	Half-life of M108	T1/2	From enrollment until 28 days after the last dose
Secondary	Immunogenicity profile of M108	Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA).	From enrollment until 28 days after the last dose
Secondary	Objective Response Rate	ORR	From first dose to disease progression , death or end of study,an average of 1 year
Secondary	Progression free survival	PFS	From first dose to disease progression , death or end of study,an average of 1 year