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RecruitingPhase 1

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests FX-111 in adult men with prostate cancer that has spread and keeps growing despite treatment to lower testosterone. It will check the drug’s safety, how the body breaks it down, and whether it slows or stops cancer growth. Participants take FX-111 by mouth each day and have regular health and lab checks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed prostate adenocarcinoma, a cancer that starts in gland cells.
  • Have a PSA level of at least 2 ng/mL at screening. PSA is a protein measured in blood; the most recent tests must show two rises in a row, at least 1 week apart.
  • Have cancer that worsened after testosterone-lowering treatment and at least one strong drug that blocks male hormones or their effects.
  • Keep taking testosterone-lowering medicine unless both testicles have been removed.
  • Meet the study’s rules for physical ability and lab test results.
  • Stop earlier treatments within the time limits set by the study.
  • Agree to use highly effective birth control during the study and for 90 days after.
  • Be willing and able to follow the visit schedule and other study rules.

Who can't join

  • The latest tumor sample is mostly small cell or neuroendocrine prostate cancer, which are specific types of prostate cancer.
  • Have cancer that has spread to the brain and needs ongoing radiation or high-dose steroid treatment.
  • Have not recovered from side effects of earlier surgery or cancer treatment.
  • Have an active viral, bacterial, or fungal infection that needs medicine.
  • Previously received an AR degrader, which breaks down the male hormone receptor, or another drug with a part that attaches to this receptor, such as a RIPTAC.
  • Had blood clots within 4 weeks before starting treatment.
  • Have another cancer needing treatment, or a past cancer active within 2 years before the first study dose. You may still qualify if it is stable or was treated with the goal of curing it.
  • Have a severe or uncontrolled illness, or another condition the study doctor thinks could interfere with checking the drug’s effects, safety, or study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study sites (10)

CA

MA

  • Massachusetts General Hospital · Boston, MA 02114Xin Gao, MD · Principal investigatorMore trials in Boston
  • Dana Farber Cancer Institute · Boston, MA 02215Mary-Ellen Taplin, MD · Principal investigatorMore trials in Boston

MI

NJ

SC

TN

TX