Study of APR-1051 in Patients With Advanced Solid Tumors

NCT06260514 | Recruiting Phase 1 FDA Drug

• 1 other identifier: APR-1051-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Treatment-related adverse events

  * 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

  Day 1 to 28, each cycle is 28 days

• Recommended dose of APR-1051

  •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

  Day 1 to 28, each cycle is 28 days

Secondary Outcomes (4)

• Pharmacokinetics: Cmax/Cmin of APR-1051

  Day 1 to 112

• Pharmacokinetics: Tmax of APR-1051

  Day 1 to 112

• Pharmacokinetics: AUC of APR-1051

  Day 1 to 112

• Pharmacokinetics: t1/2 of APR-1051

  Day 1 to 112

Study Arms (1)

APR-1051

EXPERIMENTAL

Dose Escalation based on BOIN Design

Drug: APR-1051

Interventions

APR-1051 DRUG

WEE1 Inhibitor

APR-1051

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Aprea Therapeutics: lead

Study Sites (3)

MD Anderson Cancer Center (MDACC)

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology -Dallas

Irving, Texas, 75039, United States

RECRUITING

NEXT Oncology -San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Central Study Contacts

Senior Medical Advisor

CONTACT

215-948-4119; info@aprea.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 15, 2024
• Study Start: June 13, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)