Evaluating APR-1051 for advanced solid tumors
A Phase 1, Open-Label, Multicenter, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APR-1051 in Patients With Advanced Solid Tumors
PHASE1 · Aprea Therapeutics · NCT06260514
This study is testing a new oral medication called APR-1051 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aprea Therapeutics (industry) |
| Drugs / interventions | denosumab, chemotherapy, immunotherapy, radiation |
| Locations | 3 sites (Houston, Texas and 2 other locations) |
| Trial ID | NCT06260514 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety and effectiveness of APR-1051, an oral medication, in patients with advanced solid tumors. It is a Phase 1, open-label trial that focuses on determining the pharmacokinetics and preliminary efficacy of the drug. Participants will be monitored for adverse effects and overall response to the treatment. The study aims to gather essential data that could inform future phases of clinical development.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of advanced or metastatic solid tumors and adequate organ function.
Not a fit: Patients who have recently undergone systemic anti-cancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in evaluating new treatments for advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas and 2 other locations
- MD Anderson Cancer Center (MDACC) — Houston, Texas, United States (RECRUITING)
- NEXT Oncology -Dallas — Irving, Texas, United States (RECRUITING)
- NEXT Oncology -San Antonio — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Senior Medical Advisor
- Email: info@aprea.com
- Phone: 215-948-4119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumor