Clinical trial · Interventional
A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Cancer | Liquid Tumor | ALIAS | 0.90 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| COVID-19 | — | UNRESOLVED | — |
| Sars-CoV2 | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TL-895 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Finding - 200mg BID
- description
- 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).
- interventionNames
- Drug: TL-895
Primary outcomes (1)
- measure
- Recommended dose of TL-895
- timeFrame
- After the day 14 of the 6th subject per dose level
- description
- To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available