Spots Global Cancer Trial Database for A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Gastric Cancer or Gastroesophageal Junction Cancer
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Trial Identification
Brief Title: A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Gastric Cancer or Gastroesophageal Junction Cancer
Official Title: 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
Study ID: NCT05395780
Interventions
Study Description
Brief 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)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jingsu, China
Contact Details
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