Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Idience Co., Ltd.
Study ID
NCT04725994
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IDX-1197+XELOX — DRUG
    The dose levels will be escalated following a 3+3 dose escalation scheme.
  • IDX-1197+Irinotecan — DRUG
    The dose levels will be escalated following a 3+3 dose escalation scheme.

Study Details

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.

Key Dates

Start date
Jun 28, 2021
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
87 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Group 1
  • Other: Group 2

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) [ Time Frame: through study completion (Up to 12 months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
USC Norris Comp. Cancer Ctr HospitalLos AngelesCalifornia90033-
Hematology Oncology Clinic Baton Rouge / Sarah CannonBaton RougeLouisiana70809-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Astera Cancer CareEast BrunswickNew Jersey08816-

Find similar trials in Los Angeles, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
USC Norris Comp. Cancer Ctr Hospital· Los Angeles, CAHematology Oncology Clinic Baton Rouge / Sarah Cannon· Baton Rouge, LABeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAAstera Cancer Care· East Brunswick, NJ

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