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

NCT ID: NCT04419623

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2020-12-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

TL-895

Intervention Type: DRUG

TL-895, administered by mouth

Interventions

TL-895

TL-895, administered by mouth

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Telios Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Georgia Cancer Center

Augusta, Georgia, United States

The Ohio State Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

TL-895-202

Identifier Type: -

Identifier Source: org_study_id