Clinical trial NCT06260514: Study of APR-1051 in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Aprea Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-02-15
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment-related adverse events
timeFrame: Day 1 to 28, each cycle is 28 days
measure: Recommended dose of APR-1051
timeFrame: Day 1 to 28, each cycle is 28 days
Secondary outcomes:
measure: Pharmacokinetics: Cmax/Cmin of APR-1051
timeFrame: Day 1 to 112
measure: Pharmacokinetics: Tmax of APR-1051
timeFrame: Day 1 to 112
measure: Pharmacokinetics: AUC of APR-1051
timeFrame: Day 1 to 112
measure: Pharmacokinetics: t1/2 of APR-1051
timeFrame: Day 1 to 112
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center (MDACC)
state: Texas
city: Irving
country: United States
facility: NEXT Oncology -Dallas
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology -San Antonio
state: Texas
Study officials:
References: