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

ConditionGastric Cancer (GC)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorOnconic Therapeutics Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: JPI-547 and IrinotecanExperimental treatment 2 interventions

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Onconic Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: