Study of APR-1051 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: APR-1051

• Registration Number: NCT06260514
• Lead Sponsor: Aprea Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-15
• Study Start: 2024-06-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 79

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APR-1051	APR-1051	Dose Escalation based on BOIN Design

Primary Outcome Measures

Name	Time	Method
Treatment-related adverse events	Day 1 to 28, each cycle is 28 days	* Part 1 dose escalation: Incidence of adverse Events (AE), serious AEs (SAE), treatment-related AEs, AEs that would qualify as a dose-limiting toxicity (DLT), changes in clinical laboratory values, vital signs, ECG, ECHO; * Part 1 dose escalation: Severity of adverse Events (AE), serious AEs (SAE), treatment-related AEs, and changes in clinical laboratory values, vital signs, ECG, ECHO according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Recommended dose of APR-1051	Day 1 to 28, each cycle is 28 days	•Part 1 dose escalation: Recommended Phase 2 Dose (RP2D) of APR-1051 monotherapy \[Time frame: Day 1 through to start of dose expansion phase\]. The RP2D of will be determined based on review of safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy data

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Cmax/Cmin of APR-1051	Day 1 to 112	Plasma concentration of APR-1051: maximum (Cmax), minimum (Cmin)
Pharmacokinetics: AUC of APR-1051	Day 1 to 112	Area under plasma versus time curve (AUC) of APR-1051 max)
Pharmacokinetics: Tmax of APR-1051	Day 1 to 112	Time to peak plasma concentration of APR-1051 (Tmax)
Pharmacokinetics: t1/2 of APR-1051	Day 1 to 112	Half-life of APR-1051 (t1/2)

Trial Locations

Locations (3)

NEXT Oncology -San Antonio; 🇺🇸 San Antonio, Texas, United States

MD Anderson Cancer Center (MDACC); 🇺🇸 Houston, Texas, United States

NEXT Oncology -Dallas; 🇺🇸 Irving, Texas, United States