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NCT05055609 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumor, Adult and Oncology, sponsored by Trethera.

Recruiting
Registry status
Phase 1
Development phase
94
Enrollment target
2
Study locations

NCT05055609 is a Phase 1 study of Solid Tumor, Adult and Oncology that is actively recruiting participants, run by Trethera. The registered enrollment target is 94 participants, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (50% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05055609, a Phase 1 study of Solid Tumor, Adult and Oncology, is actively recruiting participants, sponsored by Trethera.

RECRUITING
Registry status
Phase 1
Development phase
94 participants
Enrollment target
2
Study locations

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 Studied

Solid Tumor, Adult Oncology

Interventions

  • DRUG TRE-515

Study Locations (2)

California

  • UCLA - Santa Monica

North Carolina

  • Carolina BioOncology Institute - Huntersville

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2021-09-23
Est. Completion 2027-06-01
Phase Phase 1

Sponsor

Trethera

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05055609

The ClinicalTrials.gov registry entry for NCT05055609 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (50% lower). The listed sponsor is Trethera, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Solid Tumor, Adult appearing as the primary indexed condition, and to 1 intervention - of which TRE-515 is the first listed.

NCT05055609 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, North Carolina.

Frequently Asked Questions

What is clinical trial NCT05055609 about?

NCT05055609 is a clinical study titled "Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors". 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 no...

What is the current status of trial NCT05055609?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2021-09-23. Estimated completion is 2027-06-01.

What conditions does trial NCT05055609 study?

This clinical trial studies the following conditions: Solid Tumor, Adult, Oncology.

What interventions are being tested in trial NCT05055609?

The interventions under investigation include: TRE-515 (DRUG).

Who is sponsoring clinical trial NCT05055609?

This trial is sponsored by Trethera, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05055609 being conducted?

This trial has 2 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.