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

Idience

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Gastric Cancer

Treatments

Drug: IDX-1197+XELOX

Drug: IDX-1197+Irinotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT04725994

ID-VDP-103

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

Symptomatic central nervous system or uncontrolled brain metastasis
Carcinomatous meningitis or its history.
For Group 1, patients who are HER 2 positive.
Any other concurrent uncontrolled illness including, but not limited to, active or ongoing symptomatic infection requiring IV antibiotic treatment, uncontrolled diabetes, hepatic, renal, or respiratory illness.
Severe or unstable angina, myocardial infarction or ischemia, symptomatic congestive heart failure, arterial or venous thromboembolism requiring coronary artery bypass graft or stent within the past 6 months or clinically significant cardiac dysrhythmia or New York Heart Association class II ~ IV heart disease within 6 months of randomization.
Uncontrolled hypertension
Immunocompromised patients, such as patients known to be serologically positive for HIV.
Patients with known active Hepatitis B or C infection.
Patients with known active or symptomatic pneumonitis, or history of non-infectious pneumonitis requiring steroids.
Diagnosis of a myelodysplastic syndrome/acute myeloid leukemia or its suspicious characteristics.
Any unresolved clinically significant Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 toxicity
Resting ECG with measurable QTcF > 470 msec on 2 or more time points within a 24-hour period or family history of long QT syndrome.
Current use of a cytochrome P3A4 inhibitor or inducer and strong uridine diphosphate (UDP)-glucuronosyltransferase 1A1 (UGT1A1) inhibitors.