Testing a new monoclonal antibody for advanced solid tumors in China

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

This study tests a new antibody treatment for patients with advanced solid tumors to see how safe it is and what the best dosage is.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT04894825 on ClinicalTrials.gov

What this trial studies

This phase I study evaluates the safety, tolerability, and pharmacokinetic profile of M108, a monoclonal antibody targeting gastric and gastroesophageal adenocarcinomas, in patients with advanced unresectable solid tumors. Participants will receive different dosage regimens of M108 to determine the most effective and safe levels. The study aims to establish a foundation for future research on M108's efficacy in treating these types of cancers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced unresectable solid tumors confirmed by histology and at least one measurable disease site.

Not a fit: Patients with solid tumors that are resectable or those who have received certain vaccines recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are currently difficult to manage.

How similar studies have performed: While this approach is novel for M108, similar monoclonal antibody therapies have shown promise in treating advanced solid tumors in other studies.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing

• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Zhaoyu Jin, Ph.D

Conditions Advanced Unresectable Solid Tumors