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

NCT05427487 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

IVX037

Bioselected oncolytic RNA virus

BIOLOGICAL

Sintilimab

An immune checkpoint inhibitor

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    collaborator INDUSTRY

  • ImmVirx Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Darren Shafren · ImmVirx Pty Ltd

  • Oksana Zdanska · ImmVirx Pty Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-17
Primary Completion
2028-06-30
Completion
2028-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05427487 on ClinicalTrials.gov