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NCT Number: NCT07364422

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Seoul, South Korea

Location contact

SY Rha

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JPI-547

Drug

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

Irinotecan (drug)

Drug

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

Primary outcomes

  1. 1b: dose-limiting toxicity rate

    Time frame: The dose-limiting toxicity evaluation window is 28 days from C1D1.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Onconic Therapeutics Inc.

CONTACT

[email protected]

82-2-3454-0780

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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