Colorectal Cancer Clinical Trial
Official title:
A Phase 1 Open-label, Non-randomized, Multi-cohort Clinical 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 in people with micro satellite-stable (MSS) colorectal or gastroesophageal cancer metastatic to liver, or advanced ovarian cancer.
Participants will be enrolled by cohort, with a Safety Review Committee (SRC) reviewing any dose-limiting toxicities (DLT's) that develop within 21 days of the last dose of IVX037. If no DLT's are observed, the CRC may approve enrollment in the next study cohort. Participants enrolled in the first two cohorts (one and two doses, respectively) who show stable disease or better at the Day 50 radiological assessment, may receive additional doses of IVX037, up to the maximum of 3 doses. Following the dose escalation phase, up to 5 additional participants from each of the three tumour types, will be enrolled and receive IVX037 at the maximum tolerated dose. A total of fifteen (15) participants (5 from each of the 3 tumour types) at the maximum tolerated dose will provide paired tumour biopsies, one taken on Day 1 prior to IVX037 intratumoral injection and a second one taken two weeks later on Day 15. If the MTD occurs in Cohort 3, a third biopsy is requested on Day 29 (if possible) prior to IVX037 intratumoral injection. These biopsies will be used to assess for any changes in the tumour microenvironment. ;
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