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

Status
Active
Cancer Type
Stomach/ Gastric Cancer
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04725994
Protocol IDs
ID-VDP-103 (primary)
NCI-2021-09611
Study Sponsor
Idience Co., Ltd.

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

  1. Group 1, patients with treatment-naïve recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach.
  2. 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.
  3. 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.
  4. Eastern Cooperative Oncology Group (ECOG) performance status =1.
  5. Group 2 Part C, patients should have UGT1A1 genotype tested during or prior to screening.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.