Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Start
- 2025-07-28
- End
- 2028-01
- Enrollment
- 110
- Sites
- 4
- Sponsor class
- INDUSTRY
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: WEF-001. Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
Arm · public domain (ClinicalTrials.gov) · T1
Dose selection (experimental): Phase 1: WEF-001 will be administered to participating patients at 1 selected dose out of 7 possible doses. Phase 2: WEF-001 will be administered to participating patients at 1 selected dose out of 2 possible doses.
Primary outcome · public domain (ClinicalTrials.gov) · T1
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..
Primary outcome · public domain (ClinicalTrials.gov) · T1
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 · public domain (ClinicalTrials.gov) · T1
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
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 110 participants (estimated).