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

In Phase 1a, participants are treated with IVX037 alone by intratumoral administration as monotherapy. Participants will be enrolled by cohort, with a Safety Review Committee (SRC) reviewing any dose-limiting toxicities (DLTs) that develop within 21 days after the first, second, or third dose of IVX037 for Cohorts 1, 2 and 3, respectively. Cohorts in the dose escalation will consist of 3-6 participants.

Participants in Cohort 3 are permitted to receive up to seven doses of IVX037 in the absence of DLTs and at the discretion of the Investigator. The SRC will review Cohort 3 safety data once three participants have completed three doses of IVX037 and 21-days of safety data is available and will make a recommendation as to whether the dose expansion phase may commence.

In the dose expansion phase, up to 5 additional participants from each of the three tumor types will be enrolled and receive IVX037 at the MTD. A total of fifteen (15) participants (5 from each of the 3 tumor types) at the maximum tolerated dose will provide paired tumor biopsies, one taken on Day 1 prior to IVX037 intratumoral injection and a second one taken two weeks later on Day 15.

In Part 1b, a total of 45 participants (15 from each of the three tumor types) will be enrolled and receive the number of intratumoral doses of IVX037 that were deemed safe during Part 1a, in combination with an intravenous (IV) immune checkpoint inhibitor, sintilimab. Sintilimab administration will commence on Study Day 8 and be administered every three weeks (Q3wks) at 200 mg/dose through to Study Day 344.