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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
NEXT Oncology Dallas
Dallas, Texas, United States
RECRUITINGNext Oncology, San Antonio
San Antonio, Texas, United States
RECRUITINGPrincess Margareth Cancer Center
Toronto, Ontario, Canada
RECRUITINGOxford University Hospital
Headington, Oxford, United Kingdom
RECRUITINGPhase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.
Type, incidence and severity of TEAEs, SAEs and abnormal laboratory values per CTCAE v5.0. Frequency of dose interruptions, reductions, and discontinuations. Proportion of participants with DLTs at each dose level.
Time frame: Through study completion, an average of 1 year.
Phase 2: To evaluate the antitumour activity following WEF-001 administration as monotherapy.
Objective Response Rate according to Response Evaluation Criteria in Solid Tumor (RECIST) v 1.1
Time frame: Trough study completion, an average of 2 years.
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