Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04681248 |
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Expanded Access Status :
Available
First Posted : December 23, 2020
Last Update Posted : September 29, 2023
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| Condition or disease | Intervention/treatment |
|---|---|
| Esophageal Neoplasm Adenocarcinoma of the Gastroesophageal Junction GastroEsophageal Cancer Squamous Cell Carcinoma Gastric Adenocarcinoma Endometrial Cancer Uterine Cancer Ovarian Cancer Carcinosarcoma Gastric Cancer | Drug: DKN-01 |
This is a intermediate-size Expanded Access Protocol (EAP). Patients who were receiving DKN-01 in a parent study at the time of completion of the parent study, and are, in the opinion of the Investigator and Sponsor, suitable candidates for continued study drug treatment are eligible for participation in the current EAP. In this EAP, previously treated patients will receive DKN-01 at the same dose and schedule as at the time of completion of the parent study. Furthermore, patients who received DKN-01 in combination in the parent study will continue to receive the same combination agent at the same dose and schedule in the EAP.
DKN-01 naïve patients, with advanced solid tumors not eligible for enrollment to a DKN-01 clinical study but whom, in the opinion of the treating oncologist, would potentially receive benefit from treatment with DKN-01 while it is an investigational drug may be eligible for enrollment in this EAP. Eligible DKN-01 naïve patients with Wnt activating mutations will receive DKN-01 as monotherapy, administered intravenously on Day 1 of each 21-day cycle at a dose of 600 mg, with a loading dose of 600 mg of DKN-01 administered on Day 15 of Cycle 1 only.
| Study Type : | Expanded Access |
| Expanded Access Type : | Intermediate-size Population |
| See clinical trials of the intervention/treatment in this expanded access record. | |
| Official Title: | Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors |
- Drug: DKN-01
Administered by IV infusion
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
Inclusion Criteria:
- Cytologically or histologically confirmed advanced solid tumors that are inoperable, locally advanced, metastatic, or recurrent, with no standard of care treatment options, and not eligible for enrollment to a DKN-01 clinical study, may be treated with DKN-01 in this study if in the opinion of the treating oncologist, would potentially receive benefit from treatment with DKN-01 while it is an investigational drug
- Prior documentation of a known Wnt activating mutation by a CLIA-accredited laboratory. Wnt activating mutations: CTNNB1, APC, AXIN1/2, RNF43, ZNRD3, RSPO2, RSPO3
- ECOG performance status (PS) of ≤ 2 (Medical Monitor's approval is needed for enrolling a patient with PS of 2).
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Laboratory values:
- Total bilirubin ≤ 2.0 times upper limit of normal (ULN). Total bilirubin must be < 3 X ULN for patients with Gilbert's syndrome.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 X ULN (if liver metastases are present, then ≤ 5 X ULN is allowed).
- Serum creatinine ≤ 1.5 X ULN.
- Neutrophil absolute count ≥ 1,500/mm3 (≥1.5 X 109/L).
- Platelet count ≥ 75,000/mm3 (≥100 X 109/L).
- Hemoglobin ≥ 9g/dL (transfusion within 30 days of screening is permitted).
Exclusion Criteria:
- Major surgery within 4 weeks of first dose of study drug.
- Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities).
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Any of the following cardiovascular risk factors:
- Pulmonary embolism within 28 days before first dose of study drug.
- Any history of acute myocardial infarction within 6 months before first dose of study drug.
- Uncontrolled hypertension that cannot be managed by standard anti-hypertension medications within 28 days before first dose of study drug.
- Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection within 14 days of first dose of study drug.
- Active brain metastases. Patients are eligible if brain metastases are adequately treated, and patients are neurologically stable for at least 2 weeks prior to enrolment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10mg daily prednisone (or equivalent).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681248
| Contact: Leap Therapeutics, Inc. | 617-714-0360 | EarlyAccess@leaptx.com |
| United States, Alabama | |
| University of Alabama | Available |
| Birmingham, Alabama, United States, 35294 | |
| Contact 203-441-7938 DKN01.EAP@earlyaccesscare.com | |
| United States, California | |
| Cedars Sinai Medical Care Foundation | Available |
| Los Angeles, California, United States, 90025 | |
| Contact 203-441-7938 DKN01.EAP@earlyaccesscare.com | |
| United States, Illinois | |
| Northwestern University | Available |
| Chicago, Illinois, United States, 60611 | |
| Contact 203-441-7938 DKN01.EAP@earlyaccesscare.com | |
| United States, Wisconsin | |
| University of Wisconsin | Available |
| Madison, Wisconsin, United States, 53715 | |
| Contact 203-441-7938 DKN01.EAP@earlyaccesscare.com | |
| Medical College of Wisconsin | Available |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact 203-441-7938 DKN01.EAP@earlyaccesscare.com | |
| Responsible Party: | Leap Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04681248 |
| Other Study ID Numbers: |
DEK-DKK1-P206 |
| First Posted: | December 23, 2020 Key Record Dates |
| Last Update Posted: | September 29, 2023 |
| Last Verified: | September 2023 |
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DKK1 DKN-01 epithelial histology Wnt pathway endometrial |
uterine ovarian carcinosarcoma gastric cancer gastroesophageal junction |
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Adenocarcinoma Stomach Neoplasms Endometrial Neoplasms Esophageal Neoplasms Uterine Neoplasms Carcinosarcoma Mixed Tumor, Mullerian Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Uterine Diseases Head and Neck Neoplasms Esophageal Diseases Neoplasms, Complex and Mixed Sarcoma Neoplasms, Connective and Soft Tissue |