APR-1051 for Cancer

(ACESOT-1051 Trial)

Recruiting at 2 trial locations

Overseen By Senior Medical Advisor

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aprea Therapeutics

Must not be taking: Chemotherapy, Immunotherapy, others

Disqualifiers: Major surgery, Second malignancies, others

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

Compensation: Varies

Number of Visits: 28

Duration: 16 weeks

79 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors.

Will I have to stop taking my current medications?

The trial requires stopping any current anti-cancer treatments, but you can continue endocrine therapy for breast and prostate cancer and medications for bone health. Other medications are not specified, so it's best to discuss with the trial team.

Eligibility Criteria

This trial is for adults over 18 with advanced solid tumors who are relatively active (ECOG ≤1 or KPS ≥70%). They must have measurable disease, adequate organ function, and agree to use contraception. It's not suitable for those who haven't recovered from previous cancer treatment side effects, except minor neuropathy, hair loss, or skin color changes.

Inclusion Criteria

My cancer has spread to other parts of my body.

I agree to use effective birth control during the study.

My cancer can be measured or evaluated by scans.

Exclusion Criteria

I do not have another cancer that is spreading or needs treatment.

I haven't had cancer treatment within the last 2-6 weeks, depending on the type.

Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of APR-1051

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive APR-1051 with dose escalation based on BOIN Design

16 weeks

Multiple visits (in-person) for each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• APR-1051

Trial Overview APR-1051 is being tested in this Phase 1 study to see if it's safe and effective against advanced solid tumors. Participants will take APR-1051 orally. The study will also look at how the body processes the drug and any early signs of its effectiveness.

Participant Groups

Group I: APR-1051 Experimental Treatment 1 Intervention

Dose Escalation based on BOIN Design

Who Is Running the Clinical Trial?

Aprea Therapeutics

Lead Sponsor

Trials

14

Recruited

920+