A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a 2-part study comprising a Phase 1 safety lead-in (Part 1) that will determine the recommended TL-895 dose for Phase 2 (Part 2). In Part 1, 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. In Part 2, eligible subjects will be randomized in a 1:1 ratio to TL-895 with standard available treatment (SAT), or placebo with SAT. Investigators and Sponsor will be blinded to each subject's assigned study intervention throughout the course of the study.
- Solid Tumor
- Blood Cancer
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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, except where patients are receiving hydroxychloroquine or chloroquine and/or azithromycin and/or remdesivir.
- Require artificial ventilation at screening.
- Life expectancy less than 6 months.
- Advanced healthcare directive that includes do not intubate (DNI) or do not resuscitate (DNR) orders
- 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
- Phase 1/Phase 2
- Study Type
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- In Part 1, up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose. In Part 2, 64 subjects will be randomized to the recommended TL-895 dose w/ SAT (Arm 1), and 64 subjects will be randomized to Placebo w/ SAT (Arm 2).
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The control product in this study is placebo. The placebo will only be used in Part 2. Placebo will be matched in appearance and packaging to active investigational product TL-895. Investigators and Sponsor will be blinded to each subject's assigned study treatment in Part 2 (the double-blind, placebo-controlled portion of the study) via unique kit numbers on study drug cartons.
Part 1 - Dose Finding
|TL-895 orally BID at up to 3 dose levels taken continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).||
Part 2 - Arm 1 - TL-895 at recommended dose
|TL-895 orally BID at the recommended dose continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).||
Part 2 - Arm 2 - Placebo at recommended dose
|Placebo orally BID at the recommended dose continuously in 7-day cycles for 2 - 4 cycles with standard available treatment for COVID-19 (14 - 28 days of treatment).||
- Telios Pharma, Inc.
Study ContactJohn Mei