Gastric CancerPhase 1/2NCT04725994
Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer
A Phase 1/2 study testing IDX-1197+XELOX and IDX-1197+Irinotecan in people with Gastric Cancer, run by Idience Co., Ltd. at 17 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- IDX-1197+XELOX and IDX-1197+Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 28 Jun 2021to 31 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
South Korea9 sites
Dong-A University Hospital
Busan, 49201
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do
Seoul National University Bundang Hospital
Seongnam
Korea University Anam Hospital
Seoul, 02841
Korea University Guro Hospital
Seoul, 08308
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital - Yonsei Cancer Center
Seoul
United States5 sites
Hematology Oncology Clinic Baton Rouge / Sarah Cannon
Baton Rouge, Louisiana, 70809
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Astera Cancer Care
East Brunswick, New Jersey, 08816
USC Norris Comp. Cancer Ctr Hospital
Los Angeles, California, 90033
China3 sites
Beijing Cancer Hospital
Beijing
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou
Shanghai East Hospital
Shanghai
About this study
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
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.
- Conditions
- Gastric Cancer
- Being tested
- IDX-1197+XELOX, IDX-1197+Irinotecan
- Keywords
- 1197, IDX-1197, venadaparib
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDX-1197+XELOXDrug
The dose levels will be escalated following a 3+3 dose escalation scheme.
IDX-1197+IrinotecanDrug
The dose levels will be escalated following a 3+3 dose escalation scheme.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Not described Receives: Drug: IDX-1197+XELOX |
| Group 2 | Other | Not described Receives: Drug: IDX-1197+Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion (Up to 12 months)
Dose Limiting Toxicities (DLTs)
Occurrence of DLTs
Measured: during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start28 Jun 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725994
- Sponsor's protocol ID
- ID-VDP-103
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04725994
- Acronym / sponsor ID
- ID-VDP-103
- Conditions
- Gastric Cancer
- Keywords
- 1197, IDX-1197, venadaparib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Idience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: IDX-1197+XELOX |
| Group 2 | Other | Drug: IDX-1197+Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDX-1197+XELOXThe dose levels will be escalated following a 3+3 dose escalation scheme. | Drug | Group 1 |
| IDX-1197+IrinotecanThe dose levels will be escalated following a 3+3 dose escalation scheme. | Drug | Group 2 |
Primary outcome
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Time frame: 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)
Time frame: during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2
Occurrence of DLTs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IDX-1197+XELOX and IDX-1197+Irinotecan in people with Gastric Cancer, run by Idience Co., Ltd. at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Korea, United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) (time frame: through study completion (Up to 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.