Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or I… (NCT04725994) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer
United States87 participantsStarted 2021-06-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Timeframe: through study completion (Up to 12 months)
2
Dose Limiting Toxicities (DLTs)
Timeframe: during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2