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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
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 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.
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Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.