To Evaluate the Safety and Tolerability of Study Drug as a Third-line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer

NCT07364422 | Not Yet Recruiting Phase 1

• 1 other identifier: JPI-547-103
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer (GC)

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

JPI-547 and Irinotecan

EXPERIMENTAL

coadministration of JPI-547 and Irinotecan

Drug: JPI-547; Drug: Irinotecan (drug)

Interventions

JPI-547 DRUG

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

JPI-547 and Irinotecan

Irinotecan (drug) DRUG

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

JPI-547 and Irinotecan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

Study Sites (1)

Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Onconic Therapeutics Inc.

CONTACT

82-2-3454-0780; onconictherapeutics@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 23, 2026
• Study Start: February 27, 2026
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

KR (1)