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

Sponsor
Onconic Therapeutics Inc.
Study ID
NCT07364422
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastric Cancer (GC)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Feb 27, 2026
Status verified
Jan 2026
Primary completion
Feb 28, 2026
Completion
Feb 28, 2029

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JPI-547 and Irinotecan
    coadministration of JPI-547 and Irinotecan

Primary Outcome Measure

1b: dose-limiting toxicity rate [ Time Frame: The dose-limiting toxicity evaluation window is 28 days from C1D1. ]

Central Contacts

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