In short
Clinical trials are investigating WEF-001 in people with advanced KRAS-mutant solid tumours. These studies aim to learn about safety, tolerability, dose limits, and early signs of antitumour activity. The trials include adults with advanced solid tumours carrying KRAS mutations.
Key points
- Clinical trials are investigating WEF-001 in adults with advanced KRAS-mutant solid tumours. The studies are in Phase 1, with a Phase 2a part included in the trial plan. Researchers are mainly checking safety, tolerability, dose interruptions, dose reductions, dose-limiting toxicities, and lab changes. They are also looking for early signs of antitumour activity. The listed trials have the same design, with one Withdrawn and one Authorised.
Trial overview
These trials are interventional studies, which means researchers give WEF-001 and then watch what happens in the participants. Both trials study WEF-001 given by intravenous treatment, meaning it is given through a vein. The study title in both records is the same: a study to investigate WEF-001 in patients with advanced KRAS-mutant solid tumours.
Who is being studied
The target population is people with advanced KRAS-mutant solid tumours. “Advanced” means the cancer has grown or spread, and “KRAS-mutant” means the cancer has a change in the KRAS gene. The trial data do not give more detailed joining rules, such as age limits or prior treatment rules.
Study phases and goals
These are Phase 1 trials, with a Phase 2a part also described in the trial plan. 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. In Phase 2a, the main goal is to look for early signs that the treatment may help shrink tumours.
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. TEAEs are treatment-emergent adverse events, which means health problems that appear after treatment starts, and SAEs are serious adverse events. The study also measures how often treatment is interrupted, reduced, or stopped, and how many participants have dose-limiting toxicities at each dose level.
The Phase 2a endpoint is overall response rate, or ORR, using RECIST v 1.1. 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.
Trial status and enrollment
One trial record is Withdrawn and the other is Authorised. Each record lists an enrollment of 90 participants. Because the two records share the same title, phase, condition, intervention, and endpoints, they appear to describe the same study in different regulatory statuses.