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

Sponsor
Idience Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04725994
Collaborator
(none)
100
Enrollment
12
Locations
2
Arms
33.1
Anticipated Duration (Months)
8.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 28, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Group 1

Drug: IDX-1197+XELOX
The dose levels will be escalated following a 3+3 dose escalation scheme.
Other: Group 2

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 USC Norris Comp. Cancer Ctr Hospital Los Angeles California United States 90033
2 Emory University Winship Cancer Institute Atlanta Georgia United States 30322
3 Hematology Oncology Clinic Baton Rouge / Sarah Cannon Baton Rouge Louisiana United States 70809
4 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
5 Beijing Cancer Hospital Beijing China
6 The Sixth Affiliated Hospital of Sun Yat-Sen University Guangzhou China
7 Shanghai East Hospital Shanghai China
8 Seoul National University Bundang Hospital Seongnam Korea, Republic of
9 Asan Medical Center Seoul Korea, Republic of
10 Samsung Medical Center Seoul Korea, Republic of
11 Seoul National University Hospital Seoul Korea, Republic of
12 Severance Hospital - Yonsei Cancer Center Seoul Korea, Republic of

Sponsors and Collaborators

  • Idience Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Idience Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04725994
Other Study ID Numbers:
  • ID-VDP-103
First Posted:
Jan 27, 2021
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Idience Co., Ltd.
1197
IDX-1197
venadaparib
Additional relevant MeSH terms:
Stomach Neoplasms
Irinotecan

Study Results

No Results Posted as of Aug 9, 2022