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

Phase 1

Completed

• Conditions: Blood Cancer; Sars-CoV2; Carcinoma; COVID-19; Solid Tumor; Cancer
• Interventions: Drug: TL-895

• Registration Number: NCT04419623
• Lead Sponsor: Telios Pharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-05
• Study Start: 2020-07-09
• Primary Completion: 2020-09-22
• Study Completion: 2020-12-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Finding - 200mg BID	TL-895	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).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Georgia Cancer Center; 🇺🇸 Augusta, Georgia, United States

The Ohio State Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States