An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumour Activity of WEF-001 in participants with Advanced KRAS- Mutant Solid Tumours.

Condition studied

Advanced KRAS- Mutant Solid Tumours

Investigational medicinal product(s)

Eligibility

Primary endpoint

Primary Endpoints - Phase 1: 1. Type, incidence and severity of TEAEs, SAEs and abnormal laboratory values per CTCAE v5.0. 2. Frequency of dose interruptions, reductions, and discontinuations. 3. Proportion of participants with DLTs at each dose level., Primary Endpoints - Phase 2a: 1. ORR according to RECIST v 1.1.

Endpoint detail

Secondary Endpoints - Phase 1: 1. PK parameters including, but not limited to a. AUC, b. Cmax, c. Tmax, d. T1/2 e. Clearance, f. Vd. 2. BOR, with calculation of ORR as a sum of CR or PR, and DCR as a sum of CR, PR, or SD, PFS, TTR and DOR according to RECIST v 1.1., Secondary Endpoints - Phase 2a: 1. DCR, DOR, and PFS according to RECIST v 1.1. 2. Type, incidence and severity of TEAEs, SAEs and clinical laboratory abnormalities per CTCAE v5.0. 3. Frequency of dose interruptions, reductions, and discontinuations. 4. PK parameters including, but not limited to a. AUC, b. Cmax, c. Tmax, d. T1/2, e. Clearance, f. Vd.