Clinical trial NCT04725994: Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer
Official title: An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX (Capecitabine and Oxaliplatin) or Irinotecan in Patients with Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Keywords: 1197
IDX-1197
venadaparib
Lead sponsor: Idience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \&gt; 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
timeFrame: through study completion (Up to 12 months)
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comp. Cancer Ctr Hospital
state: California
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic Baton Rouge / Sarah Cannon
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-Sen University
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital - Yonsei Cancer Center
Study officials:
References: