Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors

Status:

NO_LONGER_AVAILABLE

Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors

Lead Sponsor:

Leap Therapeutics, Inc.

Conditions:

Esophageal Neoplasm

Adenocarcinoma of the Gastroesophageal Junction

Eligibility:

All Genders

18+ years

Brief Summary

An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors.

Detailed Description

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 Investiga...

Eligibility Criteria

Inclusion

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).
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

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).
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).

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04681248

Last Update

August 3 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

University of Alabama

Birmingham, Alabama, United States, 35294

Cedars Sinai Medical Care Foundation

Los Angeles, California, United States, 90025

Northwestern University

Chicago, Illinois, United States, 60611