Gastric Cancer (GC)Phase 1/2NCT07364422
To Evaluate the Safety and Tolerability of Study Drug as a Third-line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer
A Phase 1/2 study testing JPI-547 and Irinotecan (drug) in people with Gastric Cancer (GC), run by Onconic Therapeutics Inc. at 1 site in South Korea.
Trial summary
This study aims to evaluate the safety and tolerability of JPI-547 in combination with irinotecan as a third-line and beyond therapy for recurrent or metastatic gastric cancer Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer (GC)
- What is being tested?
- JPI-547 and Irinotecan (drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Feb 2026to 28 Feb 2029
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after second-line therapy.
- Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Those with at least one measurable lesion in accordance with RECIST 1.1
Who cannot join
- Patients with a confirmed specific medical history or past surgical history
- Patients who meet specific criteria regarding prior treatment
- Patients with a history of specific drug administration
- Patients with specific comorbidities.
- Patients who have undergone major surgery within 4 weeks prior to screening or are expected to require major surgery during the clinical trial are excluded. (However, those who have had minor surgeries
- Patients with symptoms at the time of screening, who have not received treatment, or who have rapidly progressing central nervous system (CNS) metastases.
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- Patients with mental disorders or altered mental status/consciousness (AMS) that impair their ability to understand this clinical trial for informed consent.
- Pregnant or Lactating Women
- Subjects with a history of severe allergic anaphylactic reactions to the investigational product and/or its components, or who have contraindications to the administration of the investigational product and/or irinotecan
- Patients considered unsuitable for this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine
Seoul
SY Rha
About this study
Official title: A Multicenter, Open-label, Single-arm, Dose-finding and Expansion Phase 1b/2 Study to Evaluate the Safety and Tolerability of JPI-547 in Combination With Irinotecan as a Third Line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer
This study aims to evaluate the safety and tolerability of JPI-547 in combination with irinotecan as a third-line and beyond therapy for recurrent or metastatic gastric cancer
- Conditions
- Gastric Cancer (GC)
- Being tested
- JPI-547, Irinotecan (drug)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JPI-547Drug
The dose levels will be escalated following a 3+3 dose escalation scheme.
Irinotecan (drug)Drug
The dose levels will be escalated following a 3+3 dose escalation scheme.
| Study group | Role | What they receive |
|---|---|---|
| JPI-547 and Irinotecan | Experimental | coadministration of JPI-547 and Irinotecan Receives: Drug: JPI-547; Drug: Irinotecan (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1b: dose-limiting toxicity rate
Measured: The dose-limiting toxicity evaluation window is 28 days from C1D1.
phase 2: Overall Response Rate (ORR) according to RECIST v1.1
Measured: At 6-week intervals through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start27 Feb 2026 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onconic Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364422
- Sponsor's protocol ID
- JPI-547-103
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Dose-finding and Expansion Phase 1b/2 Study to Evaluate the Safety and Tolerability of JPI-547 in Combination With Irinotecan as a Third Line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT07364422
- Acronym / sponsor ID
- JPI-547-103
- Conditions
- Gastric Cancer (GC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 23 Jan 2026 (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 study aims to evaluate the safety and tolerability of JPI-547 in combination with irinotecan as a third-line and beyond therapy for recurrent or metastatic gastric cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JPI-547 and Irinotecan | Experimental | Drug: JPI-547, Drug: Irinotecan (drug)coadministration of JPI-547 and Irinotecan |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after second-line therapy.
- Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Those with at least one measurable lesion in accordance with RECIST 1.1
Key exclusion criteria (10 listed)
- Patients with a confirmed specific medical history or past surgical history
- Patients who meet specific criteria regarding prior treatment
- Patients with a history of specific drug administration
- Patients with specific comorbidities.
- Patients who have undergone major surgery within 4 weeks prior to screening or are expected to require major surgery during the clinical trial are excluded. (However, those who have had minor surgeries
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 |
|---|---|---|
| JPI-547The dose levels will be escalated following a 3+3 dose escalation scheme. | Drug | JPI-547 and Irinotecan |
| Irinotecan (drug)The dose levels will be escalated following a 3+3 dose escalation scheme. | Drug | JPI-547 and Irinotecan |
Primary outcome
1b: dose-limiting toxicity rate
Time frame: The dose-limiting toxicity evaluation window is 28 days from C1D1.
phase 2: Overall Response Rate (ORR) according to RECIST v1.1
Time frame: At 6-week intervals through study completion, an average of 3 years.
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 23 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JPI-547 and Irinotecan (drug) in people with Gastric Cancer (GC), run by Onconic Therapeutics Inc. at 1 site in South Korea.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Contact Onconic Therapeutics Inc. (82-2-3454-0780, onconictherapeutics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1b: dose-limiting toxicity rate (time frame: The dose-limiting toxicity evaluation window is 28 days from C1D1.). 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 23 Jan 2026.