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New treatment option for Metastatic Castration-Resistant Prostate Cancer
Official title A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
ClinicalTrials.gov ID: NCT06842498
What this study is testing
What is FG-3246?
FG-3246 is an investigational medicine, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as FOR46.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma on all prior tumor biopsies.
- Participant with soft tissue disease and a safely accessible soft tissue tumor lesion(s) must agree to biopsy of a primary or metastatic lesion...
- Participant must have serum testosterone levels \<50 nanograms (ng)/deciliter (dL) during screening.
- Participant is required to have progressed on no more than one prior treatment with a second generation ARSI (abiraterone acetate, enzalutamide...
- Participant must have progressive mCRPC following last treatment at screening.
You likely can't join if
- Participant has received previous treatment with a therapeutic targeting CD46.
- Participant has small cell neuroendocrine carcinoma (pure or mixed) on any prior histologic evaluation of primary or metastatic lesion.
- Participant has progressed on more than one prior second-generation ARSI in any setting or has received more than two prior second-generation ARSIs...
- Participants must not have received recent anticancer treatments before enrollment. Ongoing supportive or hormonal therapies are allowed if they were...
- Participant has received any prior radiation therapy within 14 days prior to randomization.
- Participant has a known actionable mutation or gene alteration, for example, BRCA1 mutation, for which approved therapies are available, for example...
See the full eligibility criteria
- Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma on all prior tumor biopsies.
- Participant with soft tissue disease and a safely accessible soft tissue tumor lesion(s) must agree to biopsy of a primary or metastatic lesion during screening. Alternatively, participant may provide a suitable...
- Participant must have serum testosterone levels \<50 nanograms (ng)/deciliter (dL) during screening.
- Participant is required to have progressed on no more than one prior treatment with a second generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) initiated in either the castration-sensitive...
- Participant must have progressive mCRPC following last treatment at screening.
- Participant must have ≥1 metastatic lesion that is present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤28 days prior to randomization.
- Participant must have adequate organ function during screening. Key
- Participant has received previous treatment with a therapeutic targeting CD46.
- Participant has small cell neuroendocrine carcinoma (pure or mixed) on any prior histologic evaluation of primary or metastatic lesion.
- Participant has progressed on more than one prior second-generation ARSI in any setting or has received more than two prior second-generation ARSIs in any setting.
- Participants must not have received recent anticancer treatments before enrollment. Ongoing supportive or hormonal therapies are allowed if they were started well before randomization and are continued without change.
- Participant has received any prior radiation therapy within 14 days prior to randomization.
- Participant has a known actionable mutation or gene alteration, for example, BRCA1 mutation, for which approved therapies are available, for example, PARP inhibitors, unless these therapies are not appropriate for the...
- Participant has National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 2 peripheral neuropathy at the time of screening from any etiology.
- Participant has received any prior chemotherapy; however, one prior taxane-based chemotherapy in the castration-sensitive setting is allowed if completed \>12 months before randomization.
- Participant has known hypersensitivity to the components of FG-3246 or its analogs or a history of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies.
- Participant has diagnosis with any other malignancy in the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin.
- Participant requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer drug that cannot be safely discontinued. NOTE: Other protocol-defined inclusion/exclusion may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Goodyear, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Aventura, Florida, United States
- Hialeah, Florida, United States
- Atlanta, Georgia, United States
- New Orleans, Louisiana, United States
- Albuquerque, New Mexico, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Myrtle Beach, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goodyear, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.