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

NCT04419623 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TL-895-202
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

TKI; Tyrosine Kinase Inhibitor

Outcome Measures

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

  After the day 14 of the 6th subject per dose level

Study Arms (1)

Dose Finding - 200mg BID

EXPERIMENTAL

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

TL-895 DRUG

TL-895, administered by mouth

Dose Finding - 200mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Telios Pharma, Inc.: lead

Study Sites (2)

Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

The Ohio State Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

COVID-19; Neoplasms; Carcinoma; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: July 9, 2020
• Primary Completion: September 22, 2020
• Study Completion: December 15, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)