Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
NCT ID: NCT07148128
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
110 participants
INTERVENTIONAL
2025-07-28
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose selection
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.
WEF-001
Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
Interventions
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WEF-001
Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Simbec-Orion Group
INDUSTRY
Auricula Biosciences Inc.
INDUSTRY
Responsible Party
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Locations
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NEXT Oncology Dallas
Dallas, Texas, United States
Next Oncology, San Antonio
San Antonio, Texas, United States
Princess Margareth Cancer Center
Toronto, Ontario, Canada
Oxford University Hospital
Headington, Oxford, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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2024-518644-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WEF-001-01
Identifier Type: -
Identifier Source: org_study_id
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