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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Study 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.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2700
Pegfilgrastim
2013
Completed Phase 3
~4410
FOR46
2019
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

Rahul AggarwalLead Sponsor
11 Previous Clinical Trials
484 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
21 Previous Clinical Trials
1,391 Total Patients Enrolled
11 Trials studying Prostate Cancer
990 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been prior research related to the use of FOR46?

"Presently, there are 98 ongoing investigations into FOR46 with 30 of these trials in the final Phase 3. Most studies take place within Germantown, Tennessee yet 5740 healthcare facilities around the globe are running clinical research on this drug."

Answered by AI

Could you provide an estimate of the upper limit on participants in this research endeavor?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this study is actively searching for participants, which was initially published on January 19th 2022 and most recently updated in June 1st of the same year. 36 people are being recruited from a single medical centre."

Answered by AI

Are any new participants currently being admitted for this research effort?

"Affirmative. Clinicaltrials.gov's data demonstrates that enrollment for this clinical trial is ongoing; it was initially posted on 1/19/2022 and recently updated on 6/1/2022, with a target of 36 patients at one site."

Answered by AI

What desirable effects does this research endeavor hope to achieve?

"According to the data shared by Fortis Therapeutics, Inc., two-years is the primary timeframe in which they will measure Maximally tolerated dose (MTD) (Phase 1b). Additionally, secondary outcomes such as Median time to PSA progression, Median radiographic progression-free survival and Proportion of participants with a greater than or equal to 50% change in PSA (PSA50) are also being evaluated. The latter outcome specifically defines a ≥ 50% decline from baseline measurements confirmed over four weeks for those deemed psa-evaluable."

Answered by AI
~21 spots leftby Mar 2027