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
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