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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1/2, Double-Blind, Randomized, Placebo-Controlled Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer

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

Intervention / Treatment
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* Drug: TL-895


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Finding - 200mg BID<br>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). | Drug: TL-895<br>* TL-895, administered by mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recommended dose of TL-895 | To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity | After the day 14 of the 6th subject per dose level | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TKI, Tyrosine Kinase Inhibitor