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CompletedNCT04419623Updated May 12, 2021

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

A Phase 1 interventional study of TL-895 in COVID-19, Sars-CoV2 and Cancer, sponsored by Telios Pharma, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by Telios Pharma, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2020, 6 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • COVID-19
  • Sars-CoV2
  • Cancer
  • Solid Tumor
  • Carcinoma
  • Blood Cancer

Keywords

  • TKI
  • Tyrosine Kinase Inhibitor
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 7 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Telios Pharma, Inc. is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Dose Finding - 200mg BID

    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

Interventions

  • DrugTL-895

    TL-895, administered by mouth

06

What researchers measure

Primary outcomes

  1. Recommended dose of TL-895

    To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity

    Time frame: After the day 14 of the 6th subject per dose level

07

Study locations

2 sites
  • Georgia Cancer Center
    Augusta, Georgia 30912, United States
  • The Ohio State Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04419623
Lead sponsor
Telios Pharma, Inc.
Responsible party
Sponsor
First posted
Jun 5, 2020
Start date
Jul 9, 2020
Primary completion
Sep 22, 2020
Completion
Dec 15, 2020
Last update
May 12, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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