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.
Arms and Interventions
|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).
TL-895, administered by mouth
Primary Outcome Measures
- Recommended dose of TL-895 [After the day 14 of the 6th subject per dose level]
To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity
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.
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
Contacts and Locations
|1||Georgia Cancer Center||Augusta||Georgia||United States||30912|
|2||The Ohio State Comprehensive Cancer Center||Columbus||Ohio||United States||43210|
Sponsors and Collaborators
- Telios Pharma, Inc.
Study Documents (Full-Text)None provided.