A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
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.
Checked against the public recordLast updated May 12, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Telios Pharma, Inc.
- Interventions being studied
- Drug: TL-895
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Georgia Cancer CenterAugusta, Georgia
- The Ohio State Comprehensive Cancer CenterColumbus, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 12, 2021. Always confirm current availability with the study team.