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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: Recruiting Phase 1 study of Solid Tumor, Adult and Oncology, sponsored by Trethera.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
as assessed by NCI-CTCAE v5.0
Conditions Studied
Interventions
- DRUG TRE-515
Study Locations (2)
California
- UCLA - Santa Monica
North Carolina
- Carolina BioOncology Institute - Huntersville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2021-09-23 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What NCT05055609 shows while recruiting
NCT05055609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (50% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05055609's enrollment target sits among peer trials
94 43rd of 72 higher than 30 of 72 other Solid Tumor, Adult trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor, Adult trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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