Expanded Access Use of DKN-01 for Treating Advanced Solid Tumors

Sponsor: Leap Therapeutics, Inc.

Expanded Access
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04681248

Provider View

This program offers access to the investigational drug DKN-01 for patients with advanced solid tumors who have no other treatment options. It is available to those who were part of a previous study or who may benefit from the drug according to their doctor.

Patient Parameters

Program Overview

This program allows patients with advanced solid tumors to continue or start treatment with DKN-01, an investigational drug. Patients who were part of a previous study can continue their treatment under the same conditions. New patients, who have specific genetic mutations and no other treatment options, may also be eligible to receive DKN-01. The drug is given through an IV every 21 days, with an extra dose on Day 15 of the first cycle for new patients.

Description

This program provides access to DKN-01 for patients with advanced solid tumors who have no other treatment options. Patients who were part of a previous study can continue receiving DKN-01 at the same dose and schedule. New patients, who have specific genetic mutations and are not eligible for other DKN-01 studies, may also join. They will receive DKN-01 alone, given through an IV on Day 1 of each 21-day cycle, with an extra dose on Day 15 of the first cycle. This program is for patients who might benefit from DKN-01, even though it is still being studied.

Eligibility Criteria

Inclusion Criteria

  • Have advanced solid tumors that cannot be removed by surgery, have spread, or have come back, with no other treatment options.
  • Have a specific genetic mutation confirmed by a lab test.
  • Be in relatively good health, with a performance status score of 0 to 2.
  • Meet certain blood test requirements, including:
    • Total bilirubin within 2 times the normal limit (or 3 times for those with Gilbert's syndrome).
    • Liver enzymes (AST and ALT) within 3 times the normal limit (or 5 times if cancer has spread to the liver).
    • Serum creatinine within 1.5 times the normal limit.
    • Neutrophil count of at least 1,500/mm3.
    • Platelet count of at least 75,000/mm3.
    • Hemoglobin level of at least 9g/dL.

Exclusion Criteria

  • Major surgery within 4 weeks before starting the study drug.
  • Side effects from previous cancer treatments that have not improved, except for certain conditions like hair loss or nerve damage.
  • Certain heart problems, including:
    • Blood clots in the lungs within 28 days before starting the study drug.
    • Heart attack within 6 months before starting the study drug.
    • Uncontrolled high blood pressure within 28 days before starting the study drug.
  • Severe infections needing treatment within 14 days before starting the study drug.
  • Active cancer spread to the brain, unless treated and stable for at least 2 weeks without steroids or on a stable low dose.

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