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Study of APR-1051 for Advanced Solid Tumors

This study is looking at a new oral medicine called APR-1051 for people with advanced solid tumors. APR-1051 is a WEE1 Inhibitor, which means it works by targeting specific pathways in cancer cells. The main goals of this study are to find out how safe APR-1051 is, what side effects it might cause, and to determine the best dose. Researchers will also look at how well APR-1051 works. You might be able to join if you are 18 or older, have an advanced solid tumor that can be measured, and meet other health requirements. This study is currently recruiting about 90 participants.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving APR-1051. The study plans to enroll about 90 participants.
What's involved
Treatment-related side effects will be measured from Day 1 to 28, with each cycle lasting 28 days. The recommended dose of APR-1051 will also be determined during this timeframe.
Compensation
Not stated in the trial record.
Follow-up
Treatment-related adverse events and the recommended dose of APR-1051 will be measured from Day 1 to 28, with each cycle lasting 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06260514

Study of APR-1051 in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Aprea Therapeutics
~90 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:APR-1051

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment-related adverse events
Measured over Day 1 to 28, each cycle is 28 days
+1 more outcome measured

Conditions

Advanced Solid Tumor

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Solid Neoplasm

NCT06260514

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center (MDACC)

    Houston, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology -Dallas

    Irving, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology -San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology -Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • NEXT Oncology- Houston

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Senior Medical Advisor
[email protected]
215-948-4119
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 18 years
Diagnosis of advanced/metastatic solid tumor
Measurable or evaluable disease per RECIST version 1.1 (radiographic disease progression per PCWG3 criteria for patients with mCRPC)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky Performance Status (KPS) ≥ 70%
Patients must have recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation
Adequate bone marrow and organ function
Women of child-bearing potential (WOCBP) or men of child-fathering potential must agree to use adequate contraception prior to study entry

Exclusion

Patient has had prior systemic anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy) within 3 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1
Prior radiation therapy at the target lesion unless there is evidence of disease progression. If patient has had prior radiation therapy for disease progression, see Exclusion Criterion 1 for allowed interval between radiotherapy and Day 1 and recovery of AEs
Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of APR-1051
Major surgery within 21 days prior to Day 1
Concomitant treatment with other anti-cancer therapy, including chemotherapy, immunotherapy, biological therapy, radiation therapy (except palliative local radiation therapy), or other novel anti-cancer agents. Note: endocrine therapy for breast and prostate cancer is allowed along with agents to treat or prevent skeletal related events (zoledronic acid, pamidronate, denosumab)
Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy

What this trial measures

  • Treatment-related adverse eventsDay 1 to 28, each cycle is 28 days

    * Part 1 dose escalation: Incidence of adverse Events (AE), serious AEs (SAE), treatment-related AEs, AEs that would qualify as a dose-limiting toxicity (DLT), changes in clinical laboratory values, vital signs, ECG, ECHO * Part 1 dose escalation: Severity of adverse Events (AE), serious AEs (SAE), treatment-related AEs, and changes in clinical laboratory values, vital signs, ECG, ECHO according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

  • Recommended dose of APR-1051Day 1 to 28, each cycle is 28 days

    •Part 1 dose escalation: Recommended Phase 2 Dose (RP2D) of APR-1051 monotherapy \[Time frame: Day 1 through to start of dose expansion phase\]. The RP2D of will be determined based on review of safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy data