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

Gastric Cancer Clinical Trial

Official title:

An Open-Label, International, Multicenter, Phase 1b 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725994
• Other study ID #: ID-VDP-103
• Status: Recruiting
• Phase: Phase 1
• Start date: June 28, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: August 2022
• Source: Idience Co., Ltd.
• Contact: Won Sik Lee
• Phone: 82-2-526-3612
• Email: wonsiklee[@]idience.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• IDX-1197+XELOX
The dose levels will be escalated following a 3+3 dose escalation scheme.
• IDX-1197+Irinotecan
The dose levels will be escalated following a 3+3 dose escalation scheme.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	The Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou
China	Shanghai East Hospital	Shanghai
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital - Yonsei Cancer Center	Seoul
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Hematology Oncology Clinic Baton Rouge / Sarah Cannon	Baton Rouge	Louisiana
United States	USC Norris Comp. Cancer Ctr Hospital	Los Angeles	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Idience Co., Ltd.

Countries where clinical trial is conducted

United States,  China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)	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.	through study completion (Up to 12 months)
Primary	Dose Limiting Toxicities (DLTs)	Occurrence of DLTs	during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2