Official Title
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
Brief 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.

Completed
COVID-19
SARS-COV2
Cancer
Solid Tumor
Carcinoma
Blood Cancer

Drug: TL-895

TL-895, administered by mouth

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Georgia Cancer Center
Augusta, Georgia, United States

The Ohio State Comprehensive Cancer Center
Columbus, Ohio, United States

Telios Pharma, Inc.
NCT Number
Keywords
TKI
Tyrosine kinase inhibitor
MeSH Terms
COVID-19
Hematologic Neoplasms