To Evaluate the Safety and Tolerability of Study Drug as a Third-line and Beyond Therapy for Recu… (NCT07364422) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
To Evaluate the Safety and Tolerability of Study Drug as a Third-line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer
South Korea49 participantsStarted 2026-02-27
Plain-language 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
Who can participate
Age range19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
1b: dose-limiting toxicity rate
Timeframe: The dose-limiting toxicity evaluation window is 28 days from C1D1.
2
phase 2: Overall Response Rate (ORR) according to RECIST v1.1
Timeframe: At 6-week intervals through study completion, an average of 3 years.