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

Onconic Therapeutics

Status and phase

Begins enrollment this month

Phase 2

Phase 1

Conditions

Gastric Cancer (GC)

Treatments

Drug: Irinotecan (drug)

Drug: JPI-547

Study type

Interventional

Funder types

Industry

Identifiers

NCT07364422

JPI-547-103

Details and patient eligibility

About

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

Enrollment

49 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No 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.