OncoMatch/Clinical Trials/NCT05055609
Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors
Is NCT05055609 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TRE-515 for solid tumor, adult.
Treatment: TRE-515 — 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. The Primary objective is to determine the safety and maximum tolerability of TRE-515 when administered orally once daily as a single agent. The secondary objectives are to establish a recommended phase 2 dose (RP2D), to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of TRE-515, preliminary evaluation of antitumor activity, and to determine the effect of an acid reducing agent (ARA) on TRE-515 exposure. The exploratory objectives are to evaluate the relationship between TRE-515 exposure and plasma deoxynucleoside concentrations, evaluate the relationship between TRE-515 exposure and reductions in intracellular dCK on-target knockdown as measured by a \[18F\]-clofarabine (CFA) positron emission tomography (PET) probe, to evaluate the relationship between TRE-515 treatment and dCK and CDA gene expression in archived tumor tissue when available, to evaluate the relationship between tumor CDA and plasma deoxynucleoside (dC and dU) concentrations, and to explore the effect of TRE-515 treatment on gene expression in white blood cell populations.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Subjects with advanced refractory cancer for which standard curative or palliative measures do not exist or are no longer effective. 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.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anticancer therapy
Exception: hormonal therapy for control of prostate cancer allowed
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 therapies, and biological therapies
Lab requirements
Blood counts
Platelet count ≥75,000/mm3; Neutrophil count ≥1500/mm3; Hemoglobin ≥9 g/dL; Albumin >2.8 g/dL
Kidney function
Calculated creatinine clearance ≥60 mL/min
Liver function
AST, ALT ≤2.5 × ULN and ≤5 × ULN if liver metastatic disease is present; total bilirubin ≤1.5 × ULN unless due to Gilbert's syndrome, then ≤3 × ULN
Cardiac function
QTcB ≤470 msec (confirmed on triplicate ECGs performed at least 2 minutes apart) at screening and confirmed prior to dose administration on Day 1
Adequate laboratory parameters including: AST, ALT ≤2.5 × 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; Platelet count ≥75,000/mm3; Neutrophil count ≥1500/mm3; Hemoglobin ≥9 g/dL; Albumin >2.8 g/dL. 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 [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA · Santa Monica, California
- Carolina BioOncology Institute · Huntersville, North Carolina
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