Health TrialsbyHealthPanel

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

ConditionsMetastatic Castration Resistant Prostate CancermCRPCmCRPC (Metastatic Castration-resistant Prostate Cancer)Prostatic NeoplasmsProstatic Neoplasms, Castration-ResistantmCRPC or Advanced/Metastatic Solid TumorsmCRPC, Metastatic Castration Resistant Prostate CancerNeoplasms ProstateNeoplasms of Prostate
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorFlare Therapeutics Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • FX-111

    Drug

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

Treatment groups

60 Participants
are divided into 5 treatment groups
Group A: FX-111 Dose Level 1Experimental treatment 1 intervention
Group B: FX-111 Dose Level 2Experimental treatment 1 intervention
Group C: FX-111 Dose Level 3Experimental treatment 1 intervention
Group D: FX-111 Dose Level 4Experimental treatment 1 intervention
Group E: FX-111 Dose Level 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111

Time frame
Study day 1 throughout the study, estimated to be 6 months.

Secondary outcomes

1

Area Under the Concentration Time Curve

Total body exposure of FX-111

Time frame
Study day 1 throughout the study for 6 months.
2

Maximum concentration (Cmax) of FX-111 in the bloodstream.

Time frame
Study day 1 throughout the study for 6 months.
3

Time required (Tmax) to reach Cmax of FX-111 in the bloodstream.

Time frame
Study day 1 throughout the study for 6 months.
4

Rate of confirmed prostate-specific antigen (PSA) decline of ≥ 50% from baseline (PSA50).

Time frame
Baseline and every 4 weeks throughout the study, estimated to be 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Flare Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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