search
Back to results

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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IDX-1197+XELOX
IDX-1197+Irinotecan
Sponsored by
Idience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring 1197, IDX-1197, venadaparib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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.

Sites / Locations

  • USC Norris Comp. Cancer Ctr HospitalRecruiting
  • Emory University Winship Cancer InstituteRecruiting
  • Hematology Oncology Clinic Baton Rouge / Sarah Cannon
  • Fox Chase Cancer CenterRecruiting
  • Beijing Cancer Hospital
  • The Sixth Affiliated Hospital of Sun Yat-Sen University
  • Shanghai East Hospital
  • Seoul National University Bundang HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital - Yonsei Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

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.
Dose Limiting Toxicities (DLTs)
Occurrence of DLTs

Secondary Outcome Measures

Full Information

First Posted
January 13, 2021
Last Updated
August 7, 2022
Sponsor
Idience Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04725994
Brief Title
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 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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
1197, IDX-1197, venadaparib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Title
Group 2
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
IDX-1197+XELOX
Intervention Description
The dose levels will be escalated following a 3+3 dose escalation scheme.
Intervention Type
Drug
Intervention Name(s)
IDX-1197+Irinotecan
Intervention Description
The dose levels will be escalated following a 3+3 dose escalation scheme.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Description
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.
Time Frame
through study completion (Up to 12 months)
Title
Dose Limiting Toxicities (DLTs)
Description
Occurrence of DLTs
Time Frame
during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Won Sik Lee
Phone
82-2-526-3612
Email
wonsiklee@idience.com
First Name & Middle Initial & Last Name or Official Title & Degree
Minju Hong
Phone
82-2-526-3644
Email
minju.hong@idience.com
Facility Information:
Facility Name
USC Norris Comp. Cancer Ctr Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology Oncology Clinic Baton Rouge / Sarah Cannon
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Sixth Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shanghai East Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital - Yonsei Cancer Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs