Recruiting
Phase 1

APR-1051

Sponsor:

Aprea Therapeutics

Code:

NCT06260514

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

APR-1051

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumor

Study ID

NCT06260514

Start date

Jun 13, 2024

Status verified date

Oct, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: APR-1051

Dose Escalation based on BOIN Design

Interventions

APR-1051

WEE1 Inhibitor

Primary outcome measure

  • Treatment-related adverse events [ Time Frame: Day 1 to 28, each cycle is 28 days ]
  • Recommended dose of APR-1051 [ Time Frame: Day 1 to 28, each cycle is 28 days ]

Central Contacts and Locations

Central contacts

Senior Medical Advisor

215-948-4119info@aprea.com

Locations

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Mohammad Ghalib

mhg68@cinj.rutgers.edu

Kassie DiOrio

kassie.diorio@rutgers.edu

Principal Investigator:

Sanjay Goel, MD

University Hospitals, Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Amit Mahipal, MD

216-844-6031Amit.Mahipal@UHHospitals.org

Principal Investigator:

Amit Mahipal, MD

MD Anderson Cancer Center (MDACC)

Recruiting

Houston, Texas, United States, 77030

Contacts

713-745-5474jrhudy@mdanderson.org

Principal Investigator:

Timothy Yap, MD

NEXT Oncology- Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Emma Morales

832-384-7912emorales@nextoncolgy.com

Principal Investigator:

Jennifer Segar, MD

NEXT Oncology -Dallas

Recruiting

Irving, Texas, United States, 75039

Contacts

Rebecca Popiel

972-893-8800rpopiel@nextoncology.com

Principal Investigator:

Shiraj Sen, MD

NEXT Oncology -San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jordan Georg

210-580-9500jgeorg@nextoncology.com

Principal Investigator:

David Sommerhalder, MD

NEXT Oncology -Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

703-783-4518mdelarosa@nextoncology.com

Principal Investigator:

Mohamad Salkeni, MD, FRCPC

More Information

Sponsor

Aprea Therapeutics

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Aprea Therapeutics on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.