Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06260514

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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