WEF-001 for Advanced KRAS-Mutant Solid Tumors
WEF-001
Bronchial Neoplasms+23
+ Carcinoma
+ Carcinoma, Bronchogenic
Treatment Study
Summary
Study start date: July 28, 2025
Actual date on which the first participant was enrolled.This study focuses on testing a new treatment called WEF-001 for people with advanced solid tumors that have a specific change in their KRAS gene. The goal is to understand how safe and tolerable this treatment is and to see how it behaves in the body. This research is important because KRAS mutations are challenging to treat, and finding effective therapies could greatly improve outcomes for patients dealing with these types of cancers. Participants in this study will receive WEF-001 as a single treatment. Researchers will observe how the drug is processed in the body and will monitor any potential side effects. The study also aims to gather early data on how well the treatment might work against the cancer. By focusing on safety and how the drug interacts with the body, the study aims to lay the groundwork for future research that could lead to better treatment options for patients with these difficult-to-treat tumors.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.110 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Advanced KRAS-mutant solid tumor: pancreatic ductal adenocarcinoma, colorectal cancer, non small cell lung cancer, platinum-resistant serous ovarian cancer, cholangiocarcinoma or urothelial bladder cancer * Progressive disease following at least one line of standard of care therapy * Measurable disease as defined by RECIST v1.1 * ECOG ≤ 1 Exclusion Criteria: * Active systemic infection requiring anti-infective therapy within 28 days prior to first dose of IMP * Active cardiovascular disease * Having a second active primary malignancy, requiring systemic administration of any cancer-related therapy * Liver dysfunction * Untreated brain metastasis and/or unstable neurological dysfunction * Inflammatory bowel disease * Active and untreated hyperthyroidism * Lupus erythematosus within past 5 years
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Next Oncology, San Antonio
San Antonio, United StatesOxford University Hospital
Headington, United Kingdom