A Modular, Open Label, Dose Finding Phase 1/2 Clinical Trial in Patients with Solid Tumours to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PTT-4256 (RAISIC-1: Relief of Acidic Immune Suppression In Cancer)

Condition studied

Solid Tumours

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence, nature, and severity of AEs, SAEs, and TEAEs.

Endpoint detail

• Incidence, nature, and severity of AEs, SAEs, and TEAEs., • Tumour response assessment by cross-sectional imaging: objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression free survival (PFS) as assessed by RECIST v1.1 and/or iRECIST (if applicable) criteria, based on Investigator assessment, • Overall survival (OS) as assessed during study participation and via telephone follow-ups every 3 months thereafter., • Plasma PK parameters, including but not limited to: Cmin, Cmin_ss, and accumulation ratio (RA Cmin).