THE-0504 in Patients With Solid Tumors

The primary aim of the Phase 1 study is to define the Recommended Phase 2 dose and the Maximum Tolerated Dose of THE-0504, as well as to assess the safety and tolerability of escalating doses of THE-0504 administered intravenously to patients with different types of solid tumors. The study will also provide first data in humans concerning safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of THE-0504. For the first-in-human study, a model based on a classic 3+3 design following a modified Fibonacci sequence for dose escalation will be implemented. THE-0504 will be administered IV on day 1 and day 8 of a 21-day cycle. At the end of 21 days from the first treatment of the first patient, the treatment of the second patient of the first Cohort will begin (according to the dose-escalation schedule of the specific Cohort). Intra-patient dose escalation will be permitted to minimize the chance of sub-optimal dosing. The results of the Phase 1 study will drive the future clinical development of THE-0504 in Phase 2 and Phase 3 studies.