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.
Summary
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.
Arms & interventions
- DrugWEF-001
Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
Outcome measures
Primary
Phase 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.
Eligibility criteria
Study locations (2)
NEXT Oncology Dallas
Dallas, Texas, 75230
Next Oncology, San Antonio
San Antonio, Texas, 78229