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CompletedPhase 1NCT04419623
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTL-895

The study team can explain what participation involves.

Who it may be forCOVID-19 · Sars-CoV2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 12, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Telios Pharma, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Telios Pharma, Inc.
Interventions being studied
Drug: TL-895
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Targeted therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Georgia Cancer CenterAugusta, Georgia
  • The Ohio State Comprehensive Cancer CenterColumbus, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 12, 2021. Always confirm current availability with the study team.

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