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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Finding - 200mg BID 		200mg TL-895 orally BID taken continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).
  • Drug: TL-895
    TL-895, administered by mouth

More Details

Status
Completed
Sponsor
Telios Pharma, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.