Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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, 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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
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
Treatment
Masking
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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).
  • Drug: Part 1 - TL-895
    TL-895, administered by mouth
Experimental
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).
  • Drug: Part 2 - TL-895
    TL-895, administered by mouth
Placebo Comparator
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).
  • Drug: Part 2 - Placebo
    Matching Placebo (dummy pill), administered by mouth

Recruiting Locations

Tulane Medical Center
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
Telios Pharma, Inc.

Study Contact

John Mei
650-542-0136
jmei@teliospharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.