Study of APR-1051 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

— ACESOT-1051  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260514
• Other study ID #: APR-1051-001
• Status: Recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: June 2028

Study information

• Verified date: June 2024
• Source: Aprea Therapeutics
• Contact: Crystal L Miller, RN BSN
• Phone: 1-617-463-9385
• Email: crystal.miller[@]aprea.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: June 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• APR-1051
WEE1 Inhibitor

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center (MDACC)	Houston	Texas
United States	NEXT Oncology -Dallas	Irving	Texas
United States	NEXT Oncology -San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Aprea Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pharmacokinetics: Cmax/Cmin of APR-1051	Plasma concentration of APR-1051: maximum (Cmax), minimum (Cmin)	Day 1 to 112
Secondary	Pharmacokinetics: Tmax of APR-1051	Time to peak plasma concentration of APR-1051 (Tmax)	Day 1 to 112
Secondary	Pharmacokinetics: AUC of APR-1051	Area under plasma versus time curve (AUC) of APR-1051 max)	Day 1 to 112
Secondary	Pharmacokinetics: t1/2 of APR-1051	Half-life of APR-1051 (t1/2)	Day 1 to 112