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.
Drug: TL-895
TL-895, administered by mouth
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
Georgia Cancer Center
Augusta, Georgia, United States
The Ohio State Comprehensive Cancer Center
Columbus, Ohio, United States