drugset / Trial / NCT05427487
Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IVX037 | Other / unclassified | — | Other |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |