mCRPC, mCRPC (Metastatic Castration-resistant Prostate Cancer), mCRPC, Metastatic Castration Resistant Prostate Cancer, mCRPC or Advanced/Metastatic Solid Tumors, Metastatic Castration Resistant Prostate Cancer, Neoplasms of Prostate, Neoplasms Prostate, Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant
Conditions
Brief summary
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.
Interventions
DRUGFX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Sponsors
Flare Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111 | Study day 1 throughout the study, estimated to be 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Time Curve | Study day 1 throughout the study for 6 months. | Total body exposure of FX-111 |
| Maximum concentration (Cmax) of FX-111 in the bloodstream. | Study day 1 throughout the study for 6 months. | — |
| Time required (Tmax) to reach Cmax of FX-111 in the bloodstream. | Study day 1 throughout the study for 6 months. | — |
| Rate of confirmed prostate-specific antigen (PSA) decline of ≥ 50% from baseline (PSA50). | Baseline and every 4 weeks throughout the study, estimated to be 6 months. | — |
| Objective Response Rate (ORR) | Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months. | The number of patients who achieve either a Complete Response (CR) or Partial Response (PR) to FX-111. CR: disappearance of all lesions and pathologic lymph nodes. PR: ≥30% decrease in sum of lesions, no new lesions, no progression of non-target lesions. |
| Duration of Response (DoR) | Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months. | DoR is the time from initial CR or PR until disease progression. |
Countries
United States
Contacts
CONTACTJanine Koucheki, Associate Director, Clinical Operations
CONTACTCarolyn McCrone, Sr Clinical Trial Associate
Outcome results
None listed