drugset / Trial / NCT05427487

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

NCT05427487

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

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

Publications

  • Results Liu J., Tebbutt, N., Price, T., Hus, E., Al-Asady, R., Shafren, D., Zdanska, O., Croll, N., Wong, M. Phase 1a/b open-label, non-randomized, multi-centre clinical trial of intratumoral IVX037 alone and in combination with anti-PD1 in patients with advanced microsatellite stable (MSS) colorectal, gastroesophageal or ovarian cancer: trial in progress. Medical Oncology Group of Australia (MOGA) Sydney, Australia Conference Poster 2024
  • Results Liu, J., Price, T., Tebbutt, N., Hsu, E., Al-Asady, R., Shafren, D., Croll, N., Wong, M. Phase 1a open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 in patients with advanced microsatellite stable (MSS) colorectal, gastroesophageal or ovarian cancer. SITC 2023 Poster Presentation. Abstract Number 649

Drugs

EvaluationDrugModalityDoseRoute
Subject IVX037 Other / unclassified Other
Subject Sintilimab Monoclonal antibody 200 mg Intravenous