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

Sponsor

Telios Pharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04419623

Collaborator

(none)

Enrollment

Locations

Arm

5.2

Actual Duration (Months)

3.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Sars-CoV2 Cancer Solid Tumor Carcinoma Blood Cancer	Drug: TL-895	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 9, 2020

Actual Primary Completion Date :

Sep 22, 2020

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 TL-895, administered by mouth

Arm

Intervention/Treatment

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

TL-895, administered by mouth

Outcome Measures

Primary Outcome Measures

Recommended dose of TL-895 [After the day 14 of the 6th subject per dose level]
To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgia Cancer Center	Augusta	Georgia	United States	30912
2	The Ohio State Comprehensive Cancer Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Telios Pharma, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Telios Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT04419623

Other Study ID Numbers:

TL-895-202

First Posted:

Jun 5, 2020

Last Update Posted:

May 12, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Telios Pharma, Inc.

TKI

Tyrosine Kinase Inhibitor

Additional relevant MeSH terms:

COVID-19

Hematologic Neoplasms

Study Results

No Results Posted as of May 12, 2021