RecruitingPhase 1NCT05427487

Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours

A Phase 1 Open-label, Non-randomized, Multi-cohort Clinical Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours


Sponsor

ImmVirx Pty Ltd

Enrollment

70 participants

Start Date

Feb 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1 open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 as monotherapy and in combination with an immune checkpoint inhibitor in patients with advanced micro satellite-stable (MSS) colorectal cancer, or gastric or ovarian cancer. The study is run in 2 parts. Phase 1a is dose escalation IVX037 monotherapy and Phase 1b is IVX037 with checkpoint inhibitor, sintilimab.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called IVX037, which is injected directly into tumors, in people with advanced colorectal, stomach/esophageal, or ovarian cancers that have not responded to standard treatments. The aim is to stimulate the immune system to attack the cancer from within. **You may be eligible if:** - You are at least 18 years old - You have been diagnosed with advanced colorectal, gastric/gastroesophageal, or ovarian cancer - Your cancer has progressed after at least one but no more than three prior treatments - You have at least one tumor that can be directly injected (in the liver, a lymph node, or another accessible site) - Your overall health is adequate **You may NOT be eligible if:** - Your colorectal cancer has a feature called MSI-H (high microsatellite instability — these tumors respond well to other immunotherapies) - You have had more than 3 prior lines of systemic treatment - The tumors cannot be safely accessed for injection - Your total tumor burden is very large Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIVX037

Bioselected oncolytic RNA virus

BIOLOGICALSintilimab

An immune checkpoint inhibitor


Locations(3)

Sydney site

Sydney, New South Wales, Australia

South Australia site

Adelaide, South Australia, Australia

Melbourne Site

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT05427487


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