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

Completed · Phase 1

Conditions studied: COVID-19, Sars-CoV2, Cancer, Solid Tumor, Carcinoma, Blood Cancer

In brief

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.

Key facts

Study ID

NCT04419623

Run by

Telios Pharma, Inc.

People needed

7

Starts

2020-07-09

Expected to finish

2020-12-15

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Georgia Cancer Center — Augusta, Georgia, United States
• The Ohio State Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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