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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreOther 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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: FOR46 (Dose Expansion)
- Group 2: FOR46 (Dose Escalation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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