NCT07364422Not yet recruitingPhase 1
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
Onconic Therapeutics Inc.1 site in 1 country49 target enrollmentStarted: February 27, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Onconic Therapeutics Inc.
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- 1b: dose-limiting toxicity rate
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
JPI-547 and Irinotecan
Experimental
coadministration of JPI-547 and Irinotecan
Intervention: JPI-547 (Drug)
JPI-547 and Irinotecan
Experimental
coadministration of JPI-547 and Irinotecan
Intervention: Irinotecan (drug) (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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