Gastric Cancer
Conditions
Keywords
1197, IDX-1197, venadaparib
Brief 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.
Interventions
DRUGIDX-1197+XELOX
The dose levels will be escalated following a 3+3 dose escalation scheme.
DRUGIDX-1197+Irinotecan
The dose levels will be escalated following a 3+3 dose escalation scheme.
Sponsors
Idience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) | through study completion (Up to 12 months) | To determine the MTD and RP2D of IDX-1197 when given in combination with XELOX or Irinotecan. This will be accomplished by the standard 3+3 dose escalation design. If 2 of the 3 to 6 patients in a particular dose level experience a DLT, the dose escalation should be stopped at this dose level, and the MTD will be determined. |
| Dose Limiting Toxicities (DLTs) | during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2 | Occurrence of DLTs |
Countries
China, South Korea, United States
Outcome results
None listed