ICT01 in combination with IL-2 in patients with advanced solid tumors

Primary objectives: Part ICharacterize the overall safety and tolerability profile of a range of intravenous (IV) doses of ICT01 in combination with low-dose subcutaneous (LDSC) IL-2 in patients with advanced solid tumors.Part IICharacterize the preliminary antitumor activity of IV ICT01 in combination with LDSC IL-2 in patients with a specific solid tumor indication (up to 2 indications for Part 2 will be determined after Part 1).
Primary endpoints: Part IThe primary endpoint of safety and tolerability will be evaluated in this study by the incidence, severity, and relationship of TEAEs, SAEs, and TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations.Part IIPrimary endpoint: Disease control rate (DCR) comprising patients with stable disease, partial response or complete response per RECIST1.1.