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Recruiting NCT06260514

Study of APR-1051 in Patients With Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APR-1051.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug APR-1051
    WEE1 Inhibitor

Primary outcome measures

  • Treatment-related adverse events [Time frame: Day 1 to 28, each cycle is 28 days]
  • Recommended dose of APR-1051 [Time frame: Day 1 to 28, each cycle is 28 days]
Secondary outcome measures (4)
  • Pharmacokinetics: Cmax/Cmin of APR-1051 [Time frame: Day 1 to 112]
  • Pharmacokinetics: Tmax of APR-1051 [Time frame: Day 1 to 112]
  • Pharmacokinetics: AUC of APR-1051 [Time frame: Day 1 to 112]
  • Pharmacokinetics: t1/2 of APR-1051 [Time frame: Day 1 to 112]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • MD Anderson Cancer Center (MDACC) — Houston
  • NEXT Oncology -Dallas — Irving
  • NEXT Oncology -San Antonio — San Antonio

Identifiers

NCT: NCT06260514 · APR-1051-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗