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

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.

Trial Details

NCT ID
NCT05427487
Phase
PHASE1
Sponsor
ImmVirx Pty Ltd
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • IVX037
  • Sintilimab
Locations (sample)
  • Sydney, New South Wales, Australia|-33.86785,151.20732
  • Adelaide, South Australia, Australia|-34.92866,138.59863
  • Melbourne, Victoria, Australia|-37.814,144.96332

Key Eligibility Criteria

  • Has either a histologically confirmed advanced colorectal, gastric/gastroesophageal adenocarcinoma, or ovarian cancer that has progressed or is not…
  • Progressed on or after at least one prior line of systemic therapy and must not have had more than 3 prior lines. Phase 1b only: participants with …
  • Has at least one injectable tumor that meets RECIST1.1 criteria to be designated as a target lesion, and is:
  • a liver lesion 1.0 to 6.5 cm (longest diameter) meeting RECIST criteria on baseline CT scan or MRI and suitable for injection under CT or ultrasoun…

For full eligibility, visit ClinicalTrials.gov.

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