Study of APR-1051 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAprea Therapeutics
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
APR-1051
DrugWEE1 Inhibitor
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: APR-1051Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Day 1 to 28, each cycle is 28 days2
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
Time frame
Day 1 to 28, each cycle is 28 daysSecondary outcomes
1
Pharmacokinetics: Cmax/Cmin of APR-1051
Plasma concentration of APR-1051: maximum (Cmax), minimum (Cmin)
Time frame
Day 1 to 1122
Pharmacokinetics: Tmax of APR-1051
Time to peak plasma concentration of APR-1051 (Tmax)
Time frame
Day 1 to 1123
Pharmacokinetics: AUC of APR-1051
Area under plasma versus time curve (AUC) of APR-1051 max)
Time frame
Day 1 to 1124
Pharmacokinetics: t1/2 of APR-1051
Half-life of APR-1051 (t1/2)
Time frame
Day 1 to 112Sponsors and contacts
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Source ClinicalTrials.gov