NCT05395780

A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Gastric Cancer or Gastroesophageal Junction Cancer

An Open-label, Multi-center Phase II Clinical Study on MAX-40279-01 as Second or Later Lines of Treatment of Advanced Gastric Cancer or Gastroesophageal Junction Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Maxinovel Pty., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, multi-center phase II clinical study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With advanced gastric cancer or gastroesophageal junction cancer.

Detailed description

This is a single-arm, multi-center phase II clinical study. This study intends to enroll 20-30 subjects with advanced GC or GEJ adenocarcinoma on second or later lines of treatment (the tumor tissues of ≥ 50% of subjects will be tested by RNAseq, with FGOP2 TPM ≥ 9). Subjects will be randomly assigned to cohort 1 or 2 in a 1:1 ratio: Cohort 1: High-dose MAX-40279 group (10-15 subjects, 70 mg, BID, PO) Cohort 2: Low-dose MAX-40279 group (10-15 subjects, 50 mg, BID, PO)

Conditions

• Gastric Cancer
• Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
DRUG	MAX-40279	MAX-40279 capsule will be administered orally

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2022-05-27
• Last updated: 2022-06-02

Locations

1 site across 1 country: China