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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07364422

Enrollment

Registered

2026-01-23

Start date

2026-02-27

Completion date

2029-02-28

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer (GC)

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

Interventions

DRUGJPI-547

The dose levels will be escalated following a 3+3 dose escalation scheme.

DRUGIrinotecan (drug)

The dose levels will be escalated following a 3+3 dose escalation scheme.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
1b: dose-limiting toxicity rate	The dose-limiting toxicity evaluation window is 28 days from C1D1.
phase 2: Overall Response Rate (ORR) according to RECIST v1.1	At 6-week intervals through study completion, an average of 3 years.

Countries

South Korea

Contacts

CONTACTOnconic Therapeutics Inc.

onconictherapeutics@gmail.com82-2-3454-0780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026