TRE-515 for Cancer

Recruiting at 1 trial location

Overseen By Allen Clark

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Trethera

Must not be taking: Anticancer, Adjuvant, Investigational, others

Disqualifiers: Organ transplant, Uncontrolled infection, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TRE-515, targeting patients with solid tumors, a type of cancer. Researchers aim to determine the drug's safety and the maximum dose that can be taken without harm. The primary goal is to assess whether the drug can slow or stop tumor growth by affecting the cancer cells' ability to replicate their DNA. Individuals with advanced cancer unresponsive to standard treatments might be suitable for this trial, particularly if their tumors can be tracked with specific markers. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot participate if you require any prohibited medications. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that TRE-515 is likely to be safe for humans?

Research has shown that TRE-515 has undergone testing in earlier studies to ensure its safety for humans. A previous study completed the first testing phase without harmful effects, indicating that TRE-515 is safe so far. This study also confirmed that the treatment effectively targets its intended area, a positive sign of its effectiveness. Additionally, another trial found that TRE-515 is generally safe, with patients tolerating it well. No serious side effects were reported, which is reassuring for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

TRE-515 is unique because it targets cancer cells differently than most existing treatments. While many cancer therapies focus on killing rapidly dividing cells, TRE-515 operates through a novel mechanism that aims to interfere with specific pathways crucial for tumor growth and survival. This innovative approach holds promise for tackling cancers that are resistant to traditional therapies, potentially offering new hope for patients with limited options. Researchers are particularly excited about TRE-515 because it represents a new frontier in cancer treatment, which could lead to more effective and targeted strategies in the fight against this complex disease.

What evidence suggests that TRE-515 might be an effective treatment for cancer?

Research has shown that TRE-515, the investigational treatment tested in this trial, is a promising new drug for cancer treatment. It blocks a protein called deoxycytidine kinase (dCK), which aids cancer cell growth. Since cancer cells grow quickly, they are more affected by this blockage than normal cells. Early trials demonstrated that TRE-515 is safe and can target cancer cells without causing serious side effects. Additionally, some patients with advanced cancer experienced stable disease, meaning their cancer did not worsen, when treated with TRE-515. Although the research remains in the early stages, these findings suggest potential benefits for patients with solid tumors. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Measurable disease, per RECIST v1.1

I have recovered from side effects of previous cancer treatments.

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

Exclusion Criteria

QTcB prolongation of >470 msec (confirmed on triplicate ECGs performed at least 5 minutes apart)

I do not have any ongoing serious infections requiring treatment.

Known hypersensitivity to the drug or excipients contained within the drug formulation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Subjects receive TRE-515 in sequential cohorts with escalating doses to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).

21-day cycles

Visits on Day 1, 8, and 15 of each cycle

Dose Expansion

Additional subjects receive TRE-515 at the RP2D to further evaluate safety and antitumor activity.

Up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TRE-515

Trial Overview

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.

How Is the Trial Designed?

Group I: Open Label Experimental Treatment 1 Intervention

In the dose escalation portion, will enroll up to 46 subjects in five or more cohorts. The dose expansion portion will enroll up to 48 subjects. The actual number of subjects enrolled will depend on the safety data and additional evidence of antitumor activity.

Who Is Running the Clinical Trial?

Trethera

Lead Sponsor

Trials

1

Recruited

90+

Citations

1.

trethera.com

trethera.com/news/phase-1-dose-escalation-complete-therapeutic-window-safety

Phase 1 Trial of TRE-515 Shows Safety, Target Engagement

Trethera's Phase 1 trial of TRE-515 successfully completes dose escalation with no toxicities, confirming safety, target engagement, ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/10697180

Project Details

Notably, TRE-515 is the only salvage pathway inhibitor currently in clinical development, and no salvage pathway inhibitors are approved as cancer therapeutics.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05055609

NCT05055609 | Open-Label, Dose-Escalation With ...

This is a Phase 1, open label, multi-center, nonrandomized, first in human, dose escalation trial of TRE-515 designed to evaluate safety and tolerability and ...

4.

onclive.com

onclive.com/view/fda-grants-fast-track-designation-to-tre-515-plus-radioligand-therapy-in-psma-mcrpc

FDA Grants Fast Track Designation to TRE-515 Plus ...

Across dose levels, 5 patients achieved stable disease per RECIST 1.1 criteria. The majority of these patients had been heavily pretreated with ...

5.

targetedonc.com

targetedonc.com/view/fda-clears-tre-515-healthy-volunteer-study-advancing-biomarker-driven-oncology

FDA Clears TRE-515 Healthy Volunteer Study, Advancing ...

Trethera Corporation initiates a clinical trial for TRE-515, exploring its potential in oncology and autoimmune diseases while enhancing ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05055609

NCT05055609 | Open-Label, Dose-Escalation With ...

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 ...

7.

probechem.com

probechem.com/userfiles/Products/PDF/PC-38835/PC-3883501/PC-3883501_SDS.pdf

Safety Data Sheet

: (R)-DI-87, TRE-515. Formula. : C23H30N6O3S2. Molecular Weight. : 502.652. CAS No. : 2107280-55-5. Safety Data Sheet. WWW.PROBECHEM.COM. Global Supplier of ...