BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Carcinoma
Condition: Esophageal Squamous Cell Carcinoma, Gastric Carcinoma, Gastroesophageal Junction Carcinoma
MeSH terms: Carcinoma; Esophageal Squamous Cell Carcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multi-cohort study to investigate safety, PK, and preliminary anti-tumor
      activity of the monoclonal antibody BGB A317 in combination with standard chemotherapy as
      first-line treatment. Cohorts include an ESCC cohort and a gastric carcinoma (GC) or GEJ
      carcinoma cohort that will be enrolled concurrently. The study includes a screening (up to 28
      days), treatment (until disease progression, intolerable toxicity, or treatment withdrawal
      for another reason), safety follow-up (up to 30 days following last study drug treatment),
      and survival follow-up phase.
    

Detailed description: 
      The study includes an initial phase during which 6 subjects will be enrolled in each cohort
      (ESCC and GC/GEJ carcinoma). Safety data will be reviewed by a Safety Monitoring Committee
      (SMC) after the first 6 subjects in a cohort have completed at least 1 cycle (21 days) of
      treatment. During the initial phase, subjects who discontinue for a reason unrelated to
      safety before completing Cycle 1 will be replaced. If there are no new, significant or
      severe, safety signals detected, the enrollment will be expanded up to approximately 15
      subjects per cohort (treatment expansion). During the treatment expansion, subjects will not
      be replaced for any reason.

      In the ESCC cohort, subjects will be treated with BGB A317 200 mg IV on Day 1, cisplatin 80
      mg/m² IV on Day 1, and 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1
      through 5 during each 21-day cycle. Cisplatin and 5-FU will be given for up to 6 cycles and
      BGB A317 will be administered until disease progression, intolerable toxicity, or treatment
      discontinuation for any other reason.

      In the GC and GEJ carcinoma cohort, subjects will be treated with BGB A317 200 mg IV on Day
      1, oxaliplatin 130 mg/m² IV on Day 1, and capecitabine 1000 mg/m² orally twice daily (bid)
      Days 1 through 14 (14 days total) during each 21-day cycle. Oxaliplatin will be administered
      for up to 6 cycles and capecitabine and BGB A317 will be administered until disease
      progression, intolerable toxicity, or treatment discontinuation for any other reason.
    

Intervention name(s): Tislelizumab; Cisplatin; 5-FU; Oxaliplatin; Capecitabine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be treated with BGB A317 200 mg IV on Day 1 during each 21-day cycle. BGB A317 will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.; Subjects will be treated with cisplatin 80 mg/m² IV on Day 1 during each 21-day cycle. Cisplatinwill be given for up to 6 cycles.; Subjects will be treated with 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle. 5-FU will be given for up to 6 cycles.; Subjects will be treated with oxaliplatin 130 mg/m² IV on Day 1 during each 21-day cycle. Oxaliplatin will be administered for up to 6 cycles.; Subjects will be treated with capecitabine 1000 mg/m² orally twice daily (bid) Days 1 through 14 (14 days total) during each 21-day cycle. Capecitabine will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.
Other intervention name(s): BGB-A317
Intervention MeSH terms: Capecitabine; Oxaliplatin; Tislelizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment