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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
Subjects with advanced refractory cancer for which standard curative or palliative measures do not exist or are no longer effective. There is no limitation on the number or types of prior therapy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 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.

Eligible Conditions
  • Cancer
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have advanced cancer that cannot be treated with standard treatments anymore. You may have tried other treatments before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 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, it is estimated that approximately 12-24 subjects will be enrolled in four dose cohorts. The dose expansion portion will enroll 6-12 subjects.

Find a Location

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
~10 spots leftby Mar 2025