COVID-19Phase 1NCT04419623
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 study testing TL-895 in people with COVID-19 and Sars-CoV2, run by Telios Pharma, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- TL-895
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jul 2020to 15 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgia Cancer Center
Augusta, Georgia, 30912
The Ohio State Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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
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
- Being tested
- TL-895
- Keywords
- TKI, Tyrosine Kinase Inhibitor
- Medical subject headings
- COVID-19, Neoplasms, Carcinoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL-895Drug
TL-895, administered by mouth
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: TL-895 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose of TL-895
To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity
Measured: After the day 14 of the 6th subject per dose level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start9 Jul 2020
- Primary completion22 Sep 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telios Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419623
- Sponsor's protocol ID
- TL-895-202
- Status last verified
- May 2021
- First submitted
- 3 Jun 2020
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04419623
- Acronym / sponsor ID
- TL-895-202
- Conditions
- COVID-19, Sars-CoV2, Cancer, Solid Tumor, Carcinoma, Blood Cancer
- Keywords
- TKI, Tyrosine Kinase Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Telios Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.
| Arm | Type | Receives |
|---|---|---|
| Dose Finding - 200mg BID | Experimental | Drug: TL-895200mg TL-895 orally BID taken continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TL-895TL-895, administered by mouth | Drug | Dose Finding - 200mg BID |
Primary outcome
Recommended dose of TL-895
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TL-895 in people with COVID-19 and Sars-CoV2, run by Telios Pharma, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended dose of TL-895 (time frame: After the day 14 of the 6th subject per dose level). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.