Table of contents
- Trial overview
- Who is being studied
- Study phases and goals
- What the trials measure
- Trial status and enrollment
Trial overview
These trials are interventional studies, which means researchers give WEF-001 and then watch what happens in the participants.[1] Both trials study WEF-001 given by intravenous treatment, meaning it is given through a vein.[1] The study title in both records is the same: a study to investigate WEF-001 in patients with advanced KRAS-mutant solid tumours.[1][2]
Who is being studied
The target population is people with advanced KRAS-mutant solid tumours.[1][2] “Advanced” means the cancer has grown or spread, and “KRAS-mutant” means the cancer has a change in the KRAS gene.[1][2] The trial data do not give more detailed joining rules, such as age limits or prior treatment rules.[1][2]
Study phases and goals
These are Phase 1 trials, with a Phase 2a part also described in the trial plan.[1][2] In Phase 1, the main goals are to describe the safety and tolerability of WEF-001 when used alone, and to find the maximum tolerated dose and recommended Phase 2 doses.[1][2] In Phase 2a, the main goal is to look for early signs that the treatment may help shrink tumours.[1][2]
What the trials measure
The Phase 1 endpoints include the type, number, and severity of TEAEs, SAEs, and abnormal laboratory values, using CTCAE v5.0 to grade them.[1][2] TEAEs are treatment-emergent adverse events, which means health problems that appear after treatment starts, and SAEs are serious adverse events.[1][2] The study also measures how often treatment is interrupted, reduced, or stopped, and how many participants have dose-limiting toxicities at each dose level.[1][2]
The Phase 2a endpoint is overall response rate, or ORR, using RECIST v 1.1.[1][2] ORR means the share of participants whose tumours shrink or disappear on scans, and RECIST v 1.1 is a standard way to measure tumour change.[1][2]
Trial status and enrollment
One trial record is Withdrawn and the other is Authorised.[1][2] Each record lists an enrollment of 90 participants.[1][2] Because the two records share the same title, phase, condition, intervention, and endpoints, they appear to describe the same study in different regulatory statuses.[1][2]
