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Hormone Therapy

FOR46 + Enzalutamide for Prostate Cancer

Phase 1 & 2
Recruiting
Led By Rahul Aggarwal, MD
Research Sponsored by Rahul Aggarwal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be evaluable for the primary endpoint of composite response, and must have either serum PSA ≥ 2 ng/mL during Screening and/or measurable disease by RECIST 1.1 criteria
Histologically confirmed metastatic prostate adenocarcinoma
Must not have
Cardiac condition as defined as one or more of the following: Uncontrolled supraventricular arrhythmia or ventricular arrhythmia requiring treatment, New York Heart Association (NYHA) congestive heart failure class III or IV, History of unstable angina, myocardial infarction, or cerebrovascular accident within 6 months prior to Cycle 1, Day 1
Use of a prohibited concomitant medication within 7 days of first dose of FOR46, including: Strong inhibitor of CYP3A4 (boceprevir, clarithromycin, cobicistat, conivaptan, diltiazem, danoprevir/ritonavir, elvitegravir/ritonavir, grapefruit juice, idelalisib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, paritaprevir/ritonavir/ombitasvir and/or dasabuvir, posaconazole, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir, troleandomycin, and voriconazole
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing a new drug, FOR46, to see if it works well with another existing drug, enzalutamide, to treat prostate cancer that has spread and is resistant to hormone therapy.

Who is the study for?
Men with metastatic castration-resistant prostate cancer who've progressed after abiraterone treatment. They must not have had other systemic anti-cancer therapies recently, no prior CD46-targeting treatments, and should be in good physical condition (ECOG <=1). Adequate organ function is required, and they can't have brain metastases or certain heart conditions. Participants need to agree to use contraception.Check my eligibility
What is being tested?
The trial tests FOR46 combined with enzalutamide against prostate cancer that resists standard hormone therapy. FOR46 targets a protein called CD46 on cancer cells. The study aims to see if this combination improves response rates and how long patients benefit from the treatment.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to FOR46 targeting CD46 on normal cells, fatigue, blood cell count changes from Pegfilgrastim, and hormonal side effects like hot flashes or sexual dysfunction from Enzalutamide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My PSA level is 2 ng/mL or higher, or my cancer can be measured using specific criteria.
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My prostate cancer has spread and was confirmed by a biopsy.
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My testosterone levels are very low, and I am on or will stay on hormone therapy if I haven't had surgery to remove my testicles.
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I am 18 years old or older.
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My prostate cancer has worsened despite treatment with specific hormone therapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious heart condition or recent heart attack or stroke.
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I haven't taken any strong medication that affects liver enzymes in the last week.
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I am taking more than 10mg of steroids or other immunosuppressants daily.
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I have a history of seizures or conditions like brain metastasis, stroke, brain bleeding, or lung inflammation.
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I have previously been treated with FOR46 or a similar medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite response rate (CRR) (Phase 2)
Maximally tolerated dose (MTD) (Phase 1b)
Number of participants with Dose-Limiting Toxicities (Phase 1b)
Secondary outcome measures
Frequency of treatment-related, adverse events (AE)
Median duration of objective response
Median overall survival survival.
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
Participants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1, at the maximum tolerated dose (MTD) as determined in Phase 1b. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) will also be administered on Day 2 during all treatment cycles.
Group II: Does EscalationExperimental Treatment3 Interventions
Approximately 3 dose levels of FOR46 will be evaluated. Participants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) will also be administered on Day 2 during all treatment cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
Pegfilgrastim
2013
Completed Phase 3
~4440
FOR46
2019
Completed Phase 1
~90

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
Prostate cancer treatments often target the androgen receptor (AR) pathway, crucial for prostate cancer cell growth. Enzalutamide, a second-generation AR inhibitor, blocks androgen binding, AR nuclear translocation, and AR-DNA binding, effectively reducing cancer cell proliferation. This is significant for patients as it directly impedes the cancer's growth mechanism. FOR46, an investigational agent, targets CD46, a protein overexpressed in many cancers, including prostate cancer. By binding to CD46, FOR46 aims to disrupt cancer cell survival pathways. These mechanisms are vital as they offer targeted approaches to hinder cancer progression, potentially improving patient outcomes and providing options when resistance to other treatments develops.

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Who is running the clinical trial?

Rahul AggarwalLead Sponsor
12 Previous Clinical Trials
510 Total Patients Enrolled
6 Trials studying Prostate Cancer
242 Patients Enrolled for Prostate Cancer
Fortis Therapeutics, Inc.Industry Sponsor
3 Previous Clinical Trials
111 Total Patients Enrolled
1 Trials studying Prostate Cancer
24 Patients Enrolled for Prostate Cancer
Rahul Aggarwal, MDPrincipal InvestigatorUniversity of San Francisco
22 Previous Clinical Trials
1,375 Total Patients Enrolled
12 Trials studying Prostate Cancer
1,007 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05011188 — Phase 1 & 2
Prostate Cancer Research Study Groups: Does Escalation, Dose Expansion
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT05011188 — Phase 1 & 2
Enzalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011188 — Phase 1 & 2
~19 spots leftby Mar 2027
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