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Small Molecule Inhibitor

TRE-515 for Cancer

Phase 1

Recruiting

Research Sponsored by Trethera

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 to 2

Have a histologically or cytologically confirmed solid tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

Study Summary

This trial is studying the side effects and best dose of TRE-515 when given alone in treating patients with solid tumors.

Who is the study for?

Adults with confirmed solid tumors who have measurable disease and can undergo PET scans. They should be in a stable health condition (ECOG 0-2), have recovered from previous treatments, and show adequate organ function in lab tests. Participants must not have significant heart issues, other active cancers (with some exceptions), or severe medical/psychiatric conditions that could affect study compliance.Check my eligibility

What is being tested?

The trial is testing the safety and tolerability of TRE-515, an oral drug designed to disrupt cancer cell DNA replication by inhibiting dCK. The goal is to find the highest dose patients can take without serious side effects (maximum tolerable dose) and recommend a phase 2 dose while also studying how the body processes the drug.See study design

What are the potential side effects?

Specific side effects are not listed but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, liver enzyme alterations, or allergic reactions due to disruption of DNA replication in cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer diagnosis was confirmed through tissue or cell analysis.

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My advanced cancer has not responded to standard treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose-limiting toxicities

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

Secondary outcome measures

Pharmacokinetic Characterization of TRE-515-CL/F

Pharmacokinetic Characterization of TRE-515-V/F

Pharmacokinetic characterization of TRE-515- AUC

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open LabelExperimental Treatment1 Intervention

In the dose escalation portion, will enroll up to 42 subjects in six or more cohorts. The dose expansion portion will enroll up to 36 subjects. The actual number of subjects enrolled will depend on the safety data and additional evidence of antitumor activity but will not exceed an aggregate total of 85, including both the dose escalation and expansion phases.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

TretheraLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended outcome of this research?

"This 18-month medical trial's main measure of success is the incidence of dose-limiting toxicities. Other objectives include evaluating antitumor activity according to RECIST v1.1, characterizing minimum observed plasma concentration (TRE-515-Cmin), and maximum observed plasma concentration (TRE-515 Cmax)."

Answered by AI

What is the headcount of individuals taking part in this investigation?

"Affirmative. Clinicaltrials.gov indicates that this clinical study has been actively recruiting since September 23, 2021 and is still on the lookout for 36 participants from two different sites."

Answered by AI

Are there any available openings in this research project?

"According to the details found on clinicaltrials.gov, this medical study is presently recruiting patients; it was first advertised in September 2021 and was most recently updated at the end of July 2022."

Answered by AI

What possible risks can patients expect when taking TRE-515?

"Due to the limited clinical data for TRE-515, our team at Power assigned it a score of 1 on the safety scale. This is because this trial is in Phase I and there is minimal evidence backing its efficacy or safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05055609.