TRE-515 for Cancer

Recruiting at 1 trial location

Overseen By Sharon Larry

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

85 Participants Needed

Trial Summary

What is the purpose of this trial?

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 too determine the safety and maximum tolerability of TRE-515 when administered orally once daily as a single agent. The secondary objective is to establish a recommended phase 2 dose (RP2D), to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of TRE-515 preliminary evaluation of antitumor activity The exploratory objectives are to evaluate the relationship between TRE-515 exposure and plasma deoxynucleoside concentrations of deoxycytidine (dC), evaluate the relationship between TRE-515 exposure and intracellular dCK on-target knockdown as measured by a \[18F\]-clofarabine (CFA) positron emission tomography (PET) probe and to evaluate the relationship between TRE-515 treatment and dCK gene expression in archived tumor tissue when available

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.

Eligibility Criteria

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 am 18 years old or older.

I have recovered from side effects of previous cancer treatments.

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

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

Treatment Details

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.

Participant Groups

Group I: Open Label Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Trethera

Lead Sponsor

Trials

1

Recruited

90+