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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518644-21 | EudraCT Number |
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| Name | Class |
|---|---|
| Simbec-Orion Group | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WEF-001 | Drug | Starting dose of 0.3 mg/m2 q4wks IV, dose escalation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Trough study completion, an average of 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Finn, MSc | Contact | 1-438-884-9551 | inquiries@auriculabiosciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NEXT Oncology Dallas | Recruiting | Dallas | Texas | 75230 | United States |
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| Next Oncology, San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| Princess Margareth Cancer Center | Recruiting | Toronto | Ontario | Canada |
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| Oxford University Hospital | Recruiting | Headington | Oxford | 0X3 9DU | United Kingdom |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D002277 | Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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