Esophageal Squamous Cell Carcinoma, Gastric Carcinoma, Gastroesophageal Junction Carcinoma Clinical Trial
Official title:
A Phase 2, Multi-Cohort Study to Investigate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Carcinoma
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.
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.
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