COVID-19, Sars-CoV2, Cancer, Solid Tumor, Carcinoma, Blood Cancer
Conditions
Keywords
TKI, Tyrosine Kinase Inhibitor
Brief summary
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.
Interventions
DRUGTL-895
TL-895, administered by mouth
Sponsors
Telios Pharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed