FG-3246 for Prostate Cancer
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.12345
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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FG-3246 via IV infusion on Day 1 of each 21-day treatment cycle until progression or other criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FG-3246
Find a Clinic Near You
Who Is Running the Clinical Trial?
FibroGen
Lead Sponsor
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