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FOR46 for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Fortis Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male ≥ 18 years of age
Has serum testosterone levels < 50 ng/dL during screening. Patients without a history of bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analog during the course of protocol therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of FOR46 given to patients with metastatic castration-resistant prostate cancer.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease response/composite response
Occurrence of dose-limiting toxicities
Occurrence of toxicity
Secondary outcome measures
Antidrug Antibodies
Characterize FOR46 elimination
Characterize FOR46 plasma concentration
+2 more
Other outcome measures
Exploratory Endpoint: Tumor expression of CD46

Trial Design

2Treatment groups
Experimental Treatment
Group I: FOR46 (Dose Expansion)Experimental Treatment1 Intervention
Eligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will receive the maximum tolerated dose during the Dose Expansion period of the study.
Group II: FOR46 (Dose Escalation)Experimental Treatment1 Intervention
Eligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will be enrolled into escalating dose levels during the Dose Escalation period of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOR46
2019
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

Fortis Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
91 Total Patients Enrolled
2 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer
Andrew Dorr, MDStudy DirectorFortis Therapeutics, Inc.
1 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

FOR46 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03575819 — Phase 1
Prostate Cancer Research Study Groups: FOR46 (Dose Expansion), FOR46 (Dose Escalation)
Prostate Cancer Clinical Trial 2023: FOR46 Highlights & Side Effects. Trial Name: NCT03575819 — Phase 1
FOR46 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03575819 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
2019. "A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03575819.
~9 spots leftby Apr 2025
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