Trials / Active Not Recruiting
Active Not RecruitingNCT04725994
Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer
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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Idience Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IDX-1197+XELOX | The dose levels will be escalated following a 3+3 dose escalation scheme. |
| DRUG | IDX-1197+Irinotecan | The dose levels will be escalated following a 3+3 dose escalation scheme. |
Timeline
- Start date
- 2021-06-28
- Primary completion
- 2026-07-31
- Completion
- 2027-03-31
- First posted
- 2021-01-27
- Last updated
- 2026-04-17
Locations
17 sites across 3 countries: United States, China, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04725994. Inclusion in this directory is not an endorsement.