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Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors

NCT05055609 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-09-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

TRE-515

TRE-515 will be administered orally once daily at least 1 hour prior or 2 hours after eating at approximately the same time each day. Dosing will be continuous with no breaks between cycles. Subjects will continue to receive successive cycles of TRE-515 treatment as long as they do not demonstrate progressive disease, experience an unacceptable toxicity, and both the Sponsor and PI consider additional treatment with TRE-515 to be within the best interest of the subject.

Sponsors & Collaborators

  • Trethera

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2026-12-31
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05055609 on ClinicalTrials.gov