FG-3246 for Prostate Cancer

Overseen By Javier Moreno

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: FibroGen

Must be taking: LHRH analogs

Must not be taking: CYP3A4 inhibitors

Disqualifiers: Small cell carcinoma, BRCA1 mutation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Variable (21-day cycles)

75 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy 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.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take any systemic anticancer therapy or radiation therapy within 28 days before starting the trial. Also, you cannot use strong CYP3A4 inhibitor or inducer drugs that cannot be safely stopped.

Eligibility Criteria

Men with advanced prostate cancer that has resisted treatment after hormone therapy and hasn't spread to the bone only. They must have had one prior ARSI treatment, no taxane chemotherapy in the mCRPC setting, and can't have used CD46-targeting therapies before. Participants need a recent biopsy confirming adenocarcinoma without small cell neuroendocrine features and normal organ function.

Inclusion Criteria

I have been diagnosed with prostate adenocarcinoma, not small cell or mixed type.

I am willing to provide a recent biopsy or have one taken for the study.

My testosterone levels are below 50 ng/dL, and I will continue treatment to keep it low.

Exclusion Criteria

I have been treated with a CD46-targeting therapy before.

My cancer is a type of neuroendocrine or non-adenocarcinoma.

I have been treated with more than one type of advanced prostate cancer medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FG-3246 via IV infusion on Day 1 of each 21-day treatment cycle until progression or other criteria are met

Variable (21-day cycles)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FG-3246

Trial Overview The trial is testing FG-3246, an antibody-drug conjugate targeting CD46, for safety and effectiveness in treating metastatic castration-resistant prostate cancer (mCRPC) after progression on one second-generation ARSI but no prior taxane therapy specifically for mCRPC.

Participant Groups

Group I: FG-3246 2.7 mg/kg Experimental Treatment 1 Intervention

Participants will receive FG-3246 2.7 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or FibroGen decision to close the study.

Group II: FG-3246 2.4 mg/kg Experimental Treatment 1 Intervention

Participants will receive FG-3246 2.4 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or FibroGen decision to close the study.

Group III: FG-3246 1.8 mg/kg Experimental Treatment 1 Intervention

Participants will receive FG-3246 1.8 milligrams (mg)/kilogram (kg) administered via intravenous (IV) infusion on Day 1 of each 21-day treatment cycle (every 3 weeks \[Q3W\]) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or FibroGen decision to close the study.

Who Is Running the Clinical Trial?

FibroGen

Lead Sponsor

Trials

60

Recruited

15,400+

Thane Wettig

FibroGen

Chief Executive Officer since 2023

Bachelor's degree in Mechanical Engineering from Case Western Reserve University, MBA from Duke University

Dr. Mark Eisner

FibroGen

Chief Medical Officer since 2020

MD from Harvard Medical School