FG-3246 for Prostate Cancer

Recruiting at 1 trial location

Overseen By Mairead Carney

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, FG-3246, to evaluate its safety and effectiveness in treating prostate cancer that has spread and resisted previous treatments. The drug targets the protein CD46 and is administered through an IV every three weeks. The study explores different doses to determine the optimal one. Men with prostate cancer who have tried one type of hormone therapy but not chemotherapy may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in prostate cancer treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that FG-3246 produced promising results in earlier studies. In patients with advanced prostate cancer unresponsive to standard treatments, FG-3246 demonstrated its ability to fight cancer and was generally well-tolerated. Reports from these studies indicate that the side effects were manageable. This is encouraging for those considering participation in a clinical trial for FG-3246, as it suggests the treatment has been tested for safety in humans and has shown positive results. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for prostate cancer?

Researchers are excited about FG-3246 for prostate cancer because it offers a novel approach compared to traditional treatments like hormone therapy, chemotherapy, and radiation. Unlike these options, FG-3246 works by targeting a specific pathway involved in cancer progression, potentially offering a more precise attack on cancer cells. Additionally, it's administered through an intravenous infusion every three weeks, which could enhance its effectiveness by maintaining consistent drug levels in the body. This targeted action and unique delivery method might lead to better outcomes with potentially fewer side effects.

What evidence suggests that FG-3246 could be an effective treatment for prostate cancer?

Research has shown that FG-3246, a new treatment, holds promise for prostate cancer. In earlier studies, patients experienced nearly 9 months without cancer progression, outperforming other treatments. The treatment is also considered safe, with manageable side effects. FG-3246 targets specific cancer cells, enhancing the immune system's ability to fight back. Overall, early evidence suggests FG-3246 could be a strong option for those with advanced prostate cancer. Participants in this trial will receive FG-3246 at different dosages—1.8 mg/kg, 2.4 mg/kg, or 2.7 mg/kg—to evaluate its effectiveness and safety at varying levels. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1.

investor.fibrogen.com

investor.fibrogen.com/news-releases/news-release-details/fibrogen-announces-publication-results-phase-1-monotherapy-study

FG-3246 showed encouraging anti-cancer activity with ...

FG-3246 showed encouraging anti-cancer activity with an acceptable safety profile in patients with metastatic castration-resistant prostate ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO-24-01989

Phase I, First-in-Human Study of FOR46 (FG-3246), an ...

The median radiographic progression-free survival of nearly 9 months on FOR46 compares favorably with the results of standard-of-care agents ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40138611/

Phase I, First-in-Human Study of FOR46 (FG-3246 ... - PubMed

FOR46 demonstrated encouraging preliminary clinical activity with a manageable safety profile. Targeting CD46 elicited an immune priming ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06842498

A Study of FG-3246 in Participants With Metastatic ...

The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) ...

5.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/fibrogen-fg-3246-phase-1-study-results-in-metastatic-prostate-cancer/

Fibrogen FG-3246 Phase 1 Study Results in Metastatic ...

FG-3246 targets CD46, offering a novel, non-PSMA-based approach to treating this aggressive form of prostate cancer. The positive Phase 1 data ...

6.

ascopubs.org

ascopubs.org/doi/abs/10.1200/JCO-24-01989

Phase I, First-in-Human Study of FOR46 (FG-3246), an ...

FOR46, a fully human antibody conjugated to monomethyl auristatin E, targets a tumor-selective epitope of CD46, which is overexpressed in metastatic castration ...

7.

fibrogen.gcs-web.com

fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announces-presentation-positive-interim-data-phase-1b

FibroGen Announces Presentation of Positive Interim Data ...

FG-3246 and enzalutamide combination therapy led to a median radiographic progression free survival (rPFS) of 10.2 months in biomarker unselected patients