A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Официальное название

A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With Metastatic Castration-Resistant Prostate Cancer

Обзор

The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are: What are the side effects of FX-111? Does FX-111 work to reduce or prevent progression of mCRPC? The study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.

Вмешательства

• Препарат FX-111
  FX-111 will be administered orally once daily in continuous 28-day cycles.

Первичные конечные точки

• The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111 [Срок оценки: Study day 1 throughout the study, estimated to be 6 months.]

Вторичные конечные точки (6)

• Area Under the Concentration Time Curve [Срок оценки: Study day 1 throughout the study for 6 months.]
• Maximum concentration (Cmax) of FX-111 in the bloodstream. [Срок оценки: Study day 1 throughout the study for 6 months.]
• Time required (Tmax) to reach Cmax of FX-111 in the bloodstream. [Срок оценки: Study day 1 throughout the study for 6 months.]
• Rate of confirmed prostate-specific antigen (PSA) decline of ≥ 50% from baseline (PSA50). [Срок оценки: Baseline and every 4 weeks throughout the study, estimated to be 6 months.]
• Objective Response Rate (ORR) [Срок оценки: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.]
• Duration of Response (DoR) [Срок оценки: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.]

Критерии участия

Критерии включения

• Confirmed adenocarcinoma of the prostate.
• PSA levels ≥ 2 ng/mL at screening visit.
• Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.
• Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide).
• Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.
• Acceptable physical functioning and laboratory measurements, per the study protocol.
• Discontinued prior therapies within protocol-specified timeframes.
• Commit to use of highly-effective contraception while on study and for 90 days after.
• Willing and able to adhere to the study visit schedule and other protocol defined requirements.

Критерии исключения

• Predominance of small cell carcinoma of the prostate/neuroendocrine prostate cancer in most recent tumor biopsy.
• Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.
• Not recovered from side effects of prior surgery or cancer treatments.
• Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.
• Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).
• Blood clots ≤ 4 weeks prior to start of treatment.
• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.
• Any evidence of severe or uncontrolled systemic diseases.
• Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 10 центров

• START Los Angeles — Los Angeles
• Massachusetts General Hospital — Boston
• START Midwest — Grand Rapids
• START New Jersey — East Brunswick
• START Carolinas — Myrtle Beach
• Tennessee Oncology — Nashville
• START Dallas-Fort Worth — Fort Worth
• NEXT Houston — Houston
• … и ещё 2 центра

Идентификаторы

NCT: NCT07719361 · FX-111-CLINPRO-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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