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Tests treatment safety and results for Solid Tumor, Adult
Official title Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors
ClinicalTrials.gov ID: NCT05055609
What this study is testing
What is TRE-515?
TRE-515 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- TRE-515 is a first-in-class small molecule inhibitor of deoxycytidine kinase (dCK) that is being developed for oral administration in patients with solid tumors. In cancer cells, rapid and upregulated DNA replication creates high replication stress, as such, cancer cells are more susceptible than normal cells to perturbations in nucleotide metabolism by DNA-targeting treatments such as TRE-515.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have a histologically or cytologically confirmed solid tumor. people with tumors that have known biomarkers, such as PSA or CA-125, will have status...
- people with advanced refractory cancer for which standard curative or palliative measures do not exist or are no longer effective. There is no...
- Measurable disease, per RECIST v1.1, with the exception of patients without measurable disease but with a known biomarker of progression, such as...
- Male or female 18 years of age or older
- Capable of giving signed informed consent
You likely can't join if
- Candidate for potentially curative therapy.
- people receiving anticancer therapy or adjuvant therapy for other cancers or people with other known active cancer(s), with the exception of limited...
- people with a prior organ transplant.
- people with QTc corrected by Bazett's (QTcB) prolongation of \>470 msec (confirmed on triplicate ECGs performed at least 2 minutes apart) at...
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Fewer than 28 days (or fewer than 5 half-lives, whichever is shorter) from prior anticancer therapy such as chemotherapy, hormonal therapy (hormonal...
See the full eligibility criteria
- Have a histologically or cytologically confirmed solid tumor. people with tumors that have known biomarkers, such as PSA or CA-125, will have status recorded.
- people with advanced refractory cancer for which standard curative or palliative measures do not exist or are no longer effective. There is no limitation on the number or types of prior therapy.
- Measurable disease, per RECIST v1.1, with the exception of patients without measurable disease but with a known biomarker of progression, such as prostate cancer (PSA) or ovarian cancer (CA-125), with a positive status.
- Male or female 18 years of age or older
- Capable of giving signed informed consent
- Able to swallow oral capsules and tolerate intravenous blood sampling for PK, has no known intolerance or hypersensitivity to TRE-515 or excipients, and able to comply with study requirements
- Able to receive the positron emission tomography (PET) isotope and undergo PET scans, with the exception if the site lacks access to the PET diagnostic machine.
- Recovered from prior treatment-related toxicity based on Investigator and Medical Monitor assessment.
- ECOG performance status of 0 to 2.
- Adequate laboratory parameters including:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) and ≤5 × ULN if liver metastatic disease is present
- Total bilirubin ≤1.5 × ULN unless considered due to Gilbert's syndrome in which case, ≤3 × ULN
- Calculated creatinine clearance ≥60 mL/min from a blood sample
- Platelet count ≥75,000/mm3
- Neutrophil count ≥1500/mm3
- Hemoglobin ≥9 g/dL
- Albumin \>2.8 g/dL
- Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of TRE-515.
- Candidate for potentially curative therapy.
- people receiving anticancer therapy or adjuvant therapy for other cancers or people with other known active cancer(s), with the exception of limited stage surgically curable non-melatomatous skin cancer, carcinoma in...
- people with a prior organ transplant.
- people with QTc corrected by Bazett's (QTcB) prolongation of \>470 msec (confirmed on triplicate ECGs performed at least 2 minutes apart) at screening and confirmed prior to dose administration on Day 1
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Fewer than 28 days (or fewer than 5 half-lives, whichever is shorter) from prior anticancer therapy such as chemotherapy, hormonal therapy (hormonal therapy for control of prostate cancer allowed), investigational...
- Major surgery other than diagnostic surgery within 28 days of Study Day 1, radiation therapy within 28 days of Study Day 1, or palliative radiation therapy within 14 days of Study Day 1.
- Pregnant or currently breast-feeding.
- Known HIV-positive or active Hepatitis B or Hepatitis C infection.
- Psychiatric illness/social situations that would interfere with compliance with study requirements.
- History of clinically significant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure (New York Heart Association classification ≥2), unstable angina, poorly controlled arrhythmias...
- Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgement of the PI and/or Sponsor, excess risk associated with study participation or study drug...
- Cerebrovascular accident (transient ischemic attack/stroke) in the 6 months prior to study entry.TRE515-T-02
- Known hypersensitivity to the drug or excipients contained within the drug formulation.
- Use of or requirement for any of the prohibited medications
- For people enrolled into the gastric ARA substudy only, history within the past 12 months, or presence of, Stage 3 or 4 gastroesophageal reflux disease (GERD) or history of gastric reduction surgery, including a Whipple...
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
- Huntersville, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States; Huntersville, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.