A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer

• Status: Completed
• Trial end date: 2020-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telios Pharma, Inc.

Criteria

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