Clinical trial · Interventional
To Evaluate the Safety and Tolerability of Study Drug as a Third-line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer
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
NCT07364422CI-TRIAL-00101551not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan (drug) | Drug | Irinotecan | ALIAS |
| JPI-547 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JPI-547 and Irinotecan
- description
- coadministration of JPI-547 and Irinotecan
- interventionNames
- Drug: JPI-547
- Drug: Irinotecan (drug)
Primary outcomes (2)
- measure
- 1b: dose-limiting toxicity rate
- timeFrame
- The dose-limiting toxicity evaluation window is 28 days from C1D1.
- measure
- phase 2: Overall Response Rate (ORR) according to RECIST v1.1
- timeFrame
- At 6-week intervals through study completion, an average of 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.