RecruitingPhase 1NCT06260514

Study of APR-1051 in Patients With 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

Sponsor

Aprea Therapeutics

Enrollment

90 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria6

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