Back to search results

TRE-515 for Advanced Solid Tumors

This study is testing a new oral drug called TRE-515 for people with advanced solid tumors. TRE-515 is designed to target cancer cells by affecting how they make new DNA. You may be able to join if you have a solid tumor that has not responded to standard treatments or for which no standard treatments exist. The main goals are to see how safe TRE-515 is and what side effects it might cause. Researchers will also look at how the drug moves through your body and if it shows any signs of shrinking tumors. The study plans to enroll 94 participants.

Study design
This is a Phase 1, open-label (meaning you and your doctors will know you are receiving the study drug) study. It will involve a small number of participants to find the safest and most effective dose of TRE-515.
What's involved
You will take TRE-515 by mouth once daily, continuously in 21-day cycles. You will have regular assessments, including blood tests, vital signs, and scans (CT/MRI) every 8 weeks to check for tumor changes.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability of TRE-515 will be measured for up to 60 months. Dose-limiting toxicities will be assessed over the first 21 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05055609

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Trethera
~94 participants
Updated 2025-09-12 on ClinicalTrials.gov
What's tested:TRE-515

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability of TRE-515 as assessed by the Number of Participants with Adverse Events (AEs) as assessed by NCI-CTCAE v5.0Safety and tolerability of oral TRE-515
Measured over up to 60 months
+1 more outcome measured

Conditions

Solid Tumor, Adult
Oncology

Explore related trials

Solid Neoplasm

NCT05055609

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Carolina BioOncology Institute

    Huntersville, North Carolinastudy coordinator listed

    Recruiting

  • UCLA

    Santa Monica, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Allen Clark
[email protected]
1-857-998-7278
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Safety and Tolerability of TRE-515 as assessed by the Number of Participants with Adverse Events (AEs) as assessed by NCI-CTCAE v5.0Safety and tolerability of oral TRE-515up to 60 months

    as assessed by NCI-CTCAE v5.0

  • Incidence of dose-limiting toxicitiesTreatment cycle of to 21 days

    determine maximum tolerated dose of TRE-515