Actively Recruiting
Study of APR-1051 in Patients With Advanced Solid Tumors
Led by Aprea Therapeutics · Updated on 2026-04-23
90
Participants Needed
3
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of APR-1051 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of advanced or metastatic solid tumor
- Measurable or evaluable disease according to RECIST version 1.1 or radiographic progression per PCWG3 for mCRPC patients
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or Karnofsky Performance Status of 70% or higher
- Recovery to Grade 1 or baseline levels from prior cancer treatment toxicities, except Grade 2 or less neuropathy, alopecia, or skin pigmentation
- Adequate bone marrow and organ function
- Women of childbearing potential and men with reproductive potential must agree to use effective contraception before entering the study
You will not qualify if you...
- Prior systemic anti-cancer therapy within 3 weeks before Day 1, or 6 weeks for mitomycin C, nitrosourea, lomustine, or at least 5 half-lives but no less than 2 weeks
- Prior radiation therapy to the target lesion unless disease progression is evident, with required recovery period
- Treatment with any investigational agent within 30 days or 5 half-lives before first APR-1051 dose
- Major surgery within 21 days before Day 1
- Concurrent treatment with other anti-cancer therapies except allowed endocrine therapy and bone event treatments
- Active uncontrolled or metastatic second cancers requiring therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
MD Anderson Cancer Center (MDACC)
Houston, Texas, United States, 77030
Actively Recruiting
2
NEXT Oncology -Dallas
Irving, Texas, United States, 75039
Actively Recruiting
3
NEXT Oncology -San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
S
Senior Medical Advisor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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