To Evaluate the Safety and Tolerability of Study Drug as a Third-line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JPI-547, Irinotecan (drug).
- Who it may be relevant to
- Registry conditions: Gastric Cancer (GC). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Drug JPI-547
The dose levels will be escalated following a 3+3 dose escalation scheme. - Drug Irinotecan (drug)
The dose levels will be escalated following a 3+3 dose escalation scheme.
Primary outcome measures
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine — Seoul
Identifiers
NCT: NCT07364422 · JPI-547-103