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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, APR-1051, to determine its safety and effectiveness for individuals with advanced solid tumors (cancer that has spread and formed solid masses). The main goal is to establish the correct dose and assess the body's response to the treatment. It suits those diagnosed with an advanced solid tumor and experiencing symptoms that doctors can measure or assess. Participants should have mostly recovered from previous treatments and be willing to use contraception. This study excludes individuals who have recently undergone surgery or other cancer treatments. As a Phase 1 trial, this research aims to understand how APR-1051 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 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.

Is there any evidence suggesting that APR-1051 is likely to be safe for humans?

Research has shown that APR-1051 is generally safe and well-tolerated in patients with advanced solid tumors. Studies have found that some patients taking APR-1051 maintained stable disease at certain doses. Specifically, at a 100 mg dose, 3 out of 4 patients maintained stable disease without serious side effects. Reports suggest that treatment with APR-1051 is usually manageable for patients, which is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

APR-1051 is unique because it uses a dose escalation strategy based on the BOIN (Bayesian Optimal Interval) design, which is an innovative approach for determining optimal dosing in early-phase trials. Unlike standard chemotherapy or targeted therapies that might not adapt dosing based on real-time patient responses, APR-1051's method allows for more personalized adjustments. Researchers are excited about APR-1051 because this adaptive dosing could lead to more effective treatments with potentially fewer side effects, offering a promising new avenue for cancer therapy.

What evidence suggests that APR-1051 might be an effective treatment for cancer?

Research has shown that APR-1051, a new cancer treatment under investigation in this trial, may help prevent disease progression. In a recent study, 3 out of 4 patients taking a 100 mg dose of APR-1051 had stable disease, meaning their cancer did not progress. APR-1051 blocks WEE1, a protein that aids cancer cell growth, making it harder for these cells to survive. Early reports indicate that APR-1051 is safe and well-tolerated in patients with advanced solid tumors. These initial findings offer hope that APR-1051 could be an effective option for people with certain gene-altered cancers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 blood and organs are working well.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ir.aprea.com ir.aprea.com/static-files/607be471-255f-4998-83c8-66aa78f09181

Early safety and efficacy of APR-1051, a novel WEE1 ... Early safety and efficacy of APR-1051, a novel WEE1 inhibitor, in patients with cancer-associated gene alterations: Updated data from ACESOT- ...

2. aacrjournals.org aacrjournals.org/mct/article/24/10_Supplement/B011/766311/Abstract-B011-Early-safety-and-efficacy-of-APR

Early safety and efficacy of APR-1051, a novel WEE1 inhibitor ... Pancreatic cancer accounted for 13% of cases (n=2). Single cases were observed for gastric, uterine, and oropharyngeal cancer (each n=1, 7%).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06260514

Study of APR-1051 in Patients With Advanced Solid Tumors Study Overview. 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, ...

4. ir.aprea.com ir.aprea.com/news-releases/news-release-details/aprea-therapeutics-provides-clinical-update-acesot-1051-trial

Release Details The latest results show that, at the 100 mg APR-1051 dose level, 3 out of 4 patients achieved stable disease, as measured using RECIST v1.

5. onclive.com onclive.com/view/the-wee1-inhibitor-apr-1051-shows-early-safety-and-tolerability-in-advanced-mutated-solid-tumors

The WEE1 Inhibitor APR-1051 Shows Early Safety and ... Treatment with APR-1051 appears safe and well tolerated in patients with advanced solid tumors and select cancer-associated gene alterations.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06260514

Study of APR-1051 in Patients With Advanced Solid Tumors The RP2D of will be determined based on review of safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy data, Day 1 to 28, each ...