Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WEF-001.
- Who it may be relevant to
- Registry conditions: Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma, Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer, Advanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung Cancer, Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of WEF-001 in Participants With Advanced KRAS- Mutant Solid Tumours.
Overview
This is a study designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of WEF-001 as monotherapy in patients with Advanced KRAS-mutant solid tumours.
Interventions
- Drug WEF-001
Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
Primary outcome measures
- Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy. [Time frame: Through study completion, an average of 1 year.]
- Phase 2: To evaluate the antitumour activity following WEF-001 administration as monotherapy. [Time frame: Trough study completion, an average of 2 years.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- NEXT Oncology Dallas — Dallas
- Next Oncology, San Antonio — San Antonio
Canada · 1 center
- Princess Margareth Cancer Center — Toronto
United Kingdom · 1 center
- Oxford University Hospital — Headington
Identifiers
NCT: NCT07148128 · WEF-001-01 · 2024-518644-21