A Phase 1 interventional study of FX-111 in Metastatic Castration Resistant Prostate Cancer, mCRPC and mCRPC (Metastatic Castration-resistant Prostate Cancer), sponsored by Flare Therapeutics Inc.. Recruiting at 10 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Flare Therapeutics Inc. · Phase 1, Interventional, and Treatment
Among 50 studies in Prostatic Neoplasms, Castration-Resistant with a site in United States — 17 open to participants now, 23 under way, 3 of them phase 3. Prostatic Neoplasms, Castration-Resistant · United States.
Among the 50 studies in Prostatic Neoplasms, Castration-Resistant with a site in United States, this one is the 24th largest by planned enrollment of the 42 interventional ones, is one of 5 that started in 2026, is one of 15 in phase 1, reaches primary completion later than 14 of the 22 other live ones, and was the 50th registered.
85 studies on the registry are indexed under Prostatic Neoplasms, Castration-Resistant; 28 are open to participants now.
This study's planned enrollment of 60 is below the median of 82 across 62 interventional studies indexed under Prostatic Neoplasms, Castration-Resistant.
Browse Prostatic Neoplasms, Castration-Resistant studies →17 of the 50 studies in Prostatic Neoplasms, Castration-Resistant with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 25 Prostatic Neoplasms, Castration-Resistant studies recruiting now, 22 (88%) set no upper age limit and 0 (0%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →50 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 5 started in 2026.
Median enrollment 91 across the 42 interventional studies, 1,908 across the 6 observational. Of the 23 that completed or were terminated, 11 (48%) have results posted.
41 of 50 have an industry lead sponsor. The 10 most frequent:
Flare Therapeutics Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Flare Therapeutics Inc. has 1 study filed under Prostatic Neoplasms, Castration-Resistant — fewer than ten, so there is no comparison to draw.
8 of the studies in Prostatic Neoplasms, Castration-Resistant with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07225946Phase 3Janssen Research & Development, LLCA Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer | 2027-11-19 |
| NCT07697989Novartis PharmaceuticalsPluvicto Real-world Investigation in Survival in Metastatic CRPC | 2027-01-31 |
| NCT07677254Novartis PharmaceuticalsA Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer | 2027-05-31 |
| NCT07677267Novartis PharmaceuticalsA Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan | 2027-05-31 |
| NCT05519449Janux TherapeuticsStudy of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) | 2027-07 |
Among the 50 studies in Prostatic Neoplasms, Castration-Resistant with a site in United States, from their registry updates:
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.
85 studies on the registry are indexed under Prostatic Neoplasms, Castration-Resistant; 28 are open to participants now.
This study's planned enrollment of 60 is below the median of 82 across 62 interventional studies indexed under Prostatic Neoplasms, Castration-Resistant.
Browse Prostatic Neoplasms, Castration-Resistant studies →Flare Therapeutics Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Prostatic Neoplasms, Castration-Resistant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Prostatic Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: FX-111
Drug: FX-111
Drug: FX-111
Drug: FX-111
Drug: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
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.
Area Under the Concentration Time Curve
Total body exposure of FX-111
Time frame: Study day 1 throughout the study for 6 months.
Maximum concentration (Cmax) of FX-111 in the bloodstream.
Time frame: Study day 1 throughout the study for 6 months.
Time required (Tmax) to reach Cmax of FX-111 in the bloodstream.
Time frame: Study day 1 throughout the study for 6 months.
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.
Objective Response Rate (ORR)
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.
Time frame: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.
Duration of Response (DoR)
DoR is the time from initial CR or PR until disease progression.
Time frame: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Feb 2028, 19 months after the start.
How these figures are worked out, and which studies are left out of them.
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Prostatic Neoplasms, Castration-Resistant →
Flare Therapeutics Inc.