FG-3246 for metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, open-label interventional trial of FG-3246, a CD46-directed antibody-drug conjugate, in participants with metastatic castration-resistant prostate cancer (mCRPC). The study will measure safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity after participants who have progressed on one prior second-generation androgen receptor signaling inhibitor are treated with FG-3246. Participants must have castrate levels of testosterone, at least one metastatic lesion on imaging, and provide a fresh or recent archival tumor biopsy. The trial is being conducted at multiple U.S. oncology centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Western Regional Medical Center - City of Hope Phoenix Goodyear
  Goodyear, Arizona, United States Recruiting
• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• The University of Arizona Cancer Center - North Campus
  Tucson, Arizona, United States Recruiting
• VA Greater Los Angeles Healthcare System
  Los Angeles, California, United States Recruiting
• UCLA Clark Urology Center
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: Javier Moreno
• Email: jmoreno@kyntrabio.com
• Phone: 415-978-1466

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.