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A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer

Trial Status: Complete

This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a study comprising a Phase 1 safety assessment. TL-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated. Only Phase 1 of the study was enrolled and the study did not proceed into Phase 2.

Inclusion Criteria

  • Known diagnosis of active cancer that is not considered cured or disease free.
  • Confirmed COVID-19 infection as per World Health Organization (WHO) criteria with suspected pneumonia requiring hospitalization and oxygen saturation < 94% on room air or requires supplemental oxygen.
  • Adequate hematological, hepatic and renal function as would be medically expected of a cancer patient population.
  • Able to swallow and absorb oral medications.

Exclusion Criteria

  • Current active treatment with medications contraindicated for receipt of investigational product.
  • Require chemotherapy or urgent systemic therapy for active cancer that cannot be withheld.
  • No remaining available therapies for advanced or metastatic malignancies.
  • Participation in another clinical study with therapeutic intent for COVID-19
  • Require artificial ventilation at screening.
  • Life expectancy less than 6 months.
  • Medical conditions that make it unsafe to receive investigational product (for example, heart attack in the last 6 mos, unstable angina, uncontrolled arrhythmia, heart failure class 3/4, QTC interval > 480 msec; known bleeding disorders, stroke or intracranial hemorrhage in the last 6 mos; active HBV, HCV or history of HIV; GI malabsorption syndrome, small bowel resection, poorly controlled IBS; untreated/actively progressing known CNS lesions).
  • Receipt of radiation therapy to the lung or mediastinum for treatment of COVID-19

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: COMPLETED

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: COMPLETED

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Telios Pharma, Inc.

  • Primary ID TL-895-202
  • Secondary IDs NCI-2020-04458
  • Clinicaltrials.gov ID NCT04419623