RightFit
RecruitingPhase 2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) 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 FG-3246, a drug that targets a protein called CD46 on cancer cells. It looks at how safe the drug is, how well it works, and how the body handles it. It is for people whose prostate cancer has spread and worsened despite low testosterone and prior hormone-blocking treatment.

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.

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

Eligibility

Who can join

  • All past tumor samples must show prostate adenocarcinoma, a type of prostate cancer.
  • If you have a soft tissue tumor that can be safely reached, you must agree to give a new tumor sample or provide a suitable stored sample.
  • Your testosterone level must be below 50 ng/dL at screening.
  • Your cancer must have worsened after one newer hormone-blocking drug, such as abiraterone, enzalutamide, apalutamide, or darolutamide.
  • Your cancer must have spread and be getting worse after your latest treatment, despite low testosterone.
  • A CT, MRI, or bone scan taken within 28 days before study group assignment must show at least one area where cancer has spread.
  • Your organs must be working well enough at screening.

Who can't join

  • You have had a CD46-targeting treatment, or a past tumor sample showed small cell neuroendocrine cancer.
  • Your cancer worsened on more than one newer hormone-blocking drug, or you have received more than two of these drugs.
  • You recently had cancer treatment, or had radiation within 14 days before study group assignment. Some ongoing hormone or supportive treatments are allowed if started well before group assignment and kept unchanged.
  • You have had chemotherapy, except for one prior taxane treatment completed more than 12 months before study group assignment while your cancer still responded to testosterone-lowering treatment.
  • You have a gene change with an approved treatment available, unless the study doctor says that treatment is not suitable or you refuse it.
  • You have moderate or worse nerve damage, such as numbness or tingling, or certain allergies to FG-3246, similar drugs, or antibody treatments.
  • You have had another cancer in the past 5 years, except for certain skin cancers that were adequately treated.
  • You need a drug that strongly changes how a liver enzyme called CYP3A4 works and cannot safely stop it. Other study rules may also apply.

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

Official eligibility criteria

Key Inclusion 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 archival 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, apalutamide, or darolutamide) initiated in either the castration-sensitive or castration-resistant setting. * 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 Exclusion Criteria: * 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 as determined by the investigator or the participant refuses such therapy. * 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.

Study sites (23)

AZ

CA

CT

FL

GA

LA

NC

NM

OH

SC

TN

TX

VA

WA