This global, multicenter, Phase 1/2, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of adding TL-895 treatment to standard available therapy (SAT) in subjects with cancer hospitalized for COVID-19.
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in patients with cancerMedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-002259-39-HU
- Lead Sponsor
- Telios Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 146
1. Adults =18 years of age
2. Known diagnosis of active cancer that is not considered cured or disease free.
3. Confirmed COVID-19 infection as per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [e.g., respiratory, blood, urine, stool, or other bodily fluid] within 3 weeks of Cycle 1 Day 1) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen
4. Adequate hematological function independent of growth factor support for at least 7 days with the exception of pegylated G-CSF and darbepoetin which require at least 14 days, defined as
a. Absolute neutrophil count (ANC) = 1.0 × 109/L for subjects with solid malignancies. ANC = 0.75 × 109/L for subjects with hematologic malignancies
b. Platelet count = 75 × 109/L for subjects with solid malignancies. Platelet count = 50 × 109/L for subjects with hematologic malignancies
5. Adequate hepatic function defined by:
a. Total bilirubin within normal limits, if total bilirubin is >upper limit of normal (ULN), then subjects are eligible if the direct bilirubin =2.0 × ULN
b. Aspartate aminotransferase (AST) = 2.5 × ULN, and alanine aminotransferase (ALT) = 2.5 × ULN.
6. Adequate renal function defined by an estimated creatinine clearance = 30 mL/min according Cockcroft Gault
7. Ability to swallow and absorb oral medications
8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, must both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79
1. Subjects with a life expectancy of less than 6 months
2. No remaining available therapies for advanced or metastatic malignancies
3. Subjects with an advanced healthcare directive that includes a do not intubate (DNI) or do not resuscitate (DNR) orders.
5. Subjects who require chemotherapy due to active oncologic disease that cannot be suspended while receiving study treatment.
6. Subjects with new onset malignancy who require urgent systemic therapy because of active oncologic disease
7. Subjects who received systemic chemotherapy resulting in immunosuppression within 14 days of Cycle 1 Day 1.
8. Active treatment with immunomodulator medications including immune checkpoint inhibitors (PD-1, PD-L1, CTLA4 blockers) that could not be suspended for the duration of the study.
9. Subjects who received prior anti-cytokine therapy (anti-IL-6) within 5 half-lives of the drug from Cycle 1 Day 1.
10. Participation in another clinical study with therapeutic intent for COVID-19. The only exception is that patients participating in clinical trials receiving hydroxychloroquine or chloroquine and/or azithromycin and/or remdesivir will be allowed
11. Patients on warfarin at study entry
12. Patients on combined anti-platelet and therapeutic anti-coagulation therapy (LMWH or DOAC).
13. Myocardial infarct within 6 months, unstable angina, uncontrolled cardiac arrhythmia, or New York Heart Association (NYHA) class 3/4 heart failure
14. Requirement for artificial ventilation (HFNC, NiPPV, ECMO, or intubation and MV) at screening
15. Known bleeding disorders (e.g., Von Willebrand’s disease, platelet storage pool disorders, or hemophilia)
16. Stroke or intracranial hemorrhage within 6 months of Cycle 1 Day 1
17. Women who are pregnant or breastfeeding
18. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study.
19. Subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV)
20. Subjects with known history of human immunodeficiency virus (HIV)
21. Grade 2 or higher QTc prolongation (> 480 milliseconds per National Cancer Institute Common Terminology of Adverse Events [v 5.0])
22. Disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.)
23. Patients receiving radiation therapy to the lung or mediastinum for treatment of COVID-19
24. Untreated or actively progressing known CNS lesions (carcinomatous meningitis). Patients with a history of CNS lesions are eligible, provided that all of the following criteria are met:
– All known CNS lesions have been treated with radiotherapy or surgery.
– Any radiotherapy or surgery must be completed = 4 weeks prior to initiation of study treatment.
– No history of intracranial hemorrhage from CNS lesions
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method