What is the mechanism of action of this treatment?

Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces testosterone levels to slow cancer growth, and chemotherapy agents like docetaxel that kill rapidly dividing cells. Androgen receptor inhibitors such as enzalutamide and abiraterone block the action of androgens, further inhibiting cancer progression. Immunotherapies like sipuleucel-T stimulate the immune system to attack cancer cells. Antibody drug conjugates (ADCs) like FOR46 target specific proteins on cancer cells, such as CD46, delivering cytotoxic agents directly to the tumor. Understanding these mechanisms helps tailor treatments to individual patients, potentially improving outcomes and minimizing side effects.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those involving antibody drug conjugates like FOR46 targeting CD46, often include side effects such as fatigue, nausea, and infusion-related reactions. Other treatments, such as androgen deprivation therapy (ADT) combined with chemotherapy (e.g., docetaxel), can lead to more severe side effects like myelosuppression, febrile neutropenia, and increased risk of fractures. Immunotherapy agents, such as pembrolizumab, may cause immune-related adverse events including colitis, hepatitis, and endocrinopathies. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including androgen receptor inhibitors (e.g., enzalutamide, abiraterone), taxane-based chemotherapies (e.g., docetaxel), and radioligand therapies (e.g., lutetium Lu 177 vipivotide tetraxetan). While specific antibody-drug conjugates (ADCs) targeting CD46 like FOR46 are still under investigation, other targeted therapies such as PSMA-targeted agents have shown promise. Immunotherapies, including checkpoint inhibitors like pembrolizumab, have also been explored for advanced prostate cancer.

What other types of research exist?

Promising alternatives to FOR46 for prostate cancer treatment include novel monoclonal and conjugated antibodies targeting cell surface proteins such as CD19, CD22, CD37, and different epitopes of CD20, which have shown promise in relapsed B-cell malignancies. Additionally, the RET inhibitors selpercatinib and pralsetinib have demonstrated efficacy in RET-altered thyroid cancers and may offer potential benefits for prostate cancer patients with similar genetic alterations.

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89Zr-DFO-YS5 Imaging for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by Robert Flavell, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky >60%)

Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC)

Must not have

Patients who have received the same antibody (YS5) earlier as part of therapy or detection

Patients who because of age, general medical, or psychiatric condition, or physiologic status cannot give valid informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing FOR46, a medicine that targets a protein on aggressive prostate cancer cells. It helps doctors see the cancer better using special scans. The study focuses on patients with hard-to-treat prostate cancer.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They should be fairly active (able to care for themselves) and have good organ function, including liver and kidneys. Men who've had other cancers might qualify if it doesn't affect this trial's safety or results.

What is being tested?

The study is testing a new imaging agent called 89Zr-DFO-YS5 used in PET/CT or PET/MRI scans to see if it can identify a protein linked to aggressive prostate cancer. This could help develop new treatments targeting this protein.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to the imaging process such as discomfort at the injection site, allergic reactions, or side effects from contrast agents used during PET/CT or PET/MRI scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am mostly self-sufficient and can carry out daily activities.

Select...

My prostate cancer has spread and does not respond to hormone therapy.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have previously received the YS5 antibody.

Select...

I am unable to give informed consent due to my age, health, or mental condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average SUVmax (SUVmax-ave) (Cohort C)

Median SUVmax (Cohort C)

Optimal antibody dose for imaging using 89Zr-DFO-YS5 PET (Cohort B)

+2 more

Secondary study objectives

Average organ uptake of 89Zr-DFO-YS5 (Cohort C)

Inter-participant heterogeneity (Cohort C)

Inter-tumoral heterogeneity (Cohort C)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort D: 89Zr-DFO-YS5, Optimal dose YS5 antibody, Multiple ScansExperimental Treatment4 Interventions

Participants will receive optimal dose of YS5 prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a series of whole body PET scans performed at 1-4 hours, approximately 20-28 hours, 48-96 hours, and 120-168 hours post injection for up to 4 scans total. Participants in have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.

Group II: Cohort C: 89Zr-DFO-YS5, Optimal dose YS5 antibodyExperimental Treatment4 Interventions

Participants receive optimal dose of YS5 antibody prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a single whole body PET scan at the optimal time determined in Cohort A. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.

Group III: Cohort B: 89Zr-DFO-YS5, YS5 antibodyExperimental Treatment4 Interventions

Participants receive either a 20mg or 50mg dose of YS5 prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a single whole body PET scan at the optimal time determined in Cohort A. The optimal dose of unmodified YS5 antibody will be used in the following cohorts C \& D. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.

Group IV: Cohort A: 89Zr-DFO-YS5Experimental Treatment3 Interventions

Participants receive one dose of 89Zr-DFO-YS5 up to 3 millicurie (mCi), and undergo a whole body PET performed at 1-4 hours, approximately 20-28 hours, 48-96 hours, and 120-168 hours post injection for up to 4 scans total. The optimized scan time will be used for imaging in cohorts B and C. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces testosterone levels to slow cancer growth, and chemotherapy agents like docetaxel that kill rapidly dividing cells. Androgen receptor inhibitors such as enzalutamide and abiraterone block the action of androgens, further inhibiting cancer progression. Immunotherapies like sipuleucel-T stimulate the immune system to attack cancer cells. Antibody drug conjugates (ADCs) like FOR46 target specific proteins on cancer cells, such as CD46, delivering cytotoxic agents directly to the tumor. Understanding these mechanisms helps tailor treatments to individual patients, potentially improving outcomes and minimizing side effects.

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