An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX (Capecitabine and Oxaliplatin) or Irinotecan in Patients with Advanced Gastric Cancer
Who is this study for? Adult patients with Gastric Cancer
What treatments are being studied? IDX-1197
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Group 1, patients with treatment-naïve recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach.
• Group 2, patients with recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach, who were treated ≥2 times with palliative chemotherapy before screening.
• At least 1 evaluable lesion for the dose escalation part and at least 1 measurable lesion according to RECIST v1.1 for the dose expansion part.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• Group 2 Part C, patients should have UGT1A1 genotype tested during or prior to screening.
Locations
United States
California
USC Norris Comp. Cancer Ctr Hospital
RECRUITING
Los Angeles
Louisiana
Hematology Oncology Clinic Baton Rouge / Sarah Cannon
NOT_YET_RECRUITING
Baton Rouge
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
Other Locations
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
The Sixth Affiliated Hospital of Sun Yat-Sen University