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A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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ClinicalTrials.gov Identifier: NCT03575819
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Fortis Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 20, 2018
First Posted Date  ICMJE July 3, 2018
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE February 4, 2019
Estimated Primary Completion Date April 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Occurrence of toxicity [ Time Frame: Through 1 month following last dose ]
    Type, incidence, severity, seriousness, and relatedness of adverse events.
  • Occurrence of dose-limiting toxicities [ Time Frame: Through 1 month following last dose ]
    The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46
  • Disease response/composite response [ Time Frame: 12 months ]
    Decline in serum prostate-specific antigen greater than 50% from baseline, confirmed by repeat measurement and objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03575819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Characterize FOR46 plasma concentration [ Time Frame: Through 1 month following last dose ]
    FOR46 maximum plasma concentration
  • Characterize the FOR46 area under the curve [ Time Frame: Through 1 month following last dose ]
    FOR46 area under the plasma concentration-time curve
  • Characterize FOR46 elimination [ Time Frame: Through 1 month following last dose ]
    FOR46 elimination half-life
  • Antidrug Antibodies [ Time Frame: Through 1 month following last dose ]
    Change from baseline in serum levels of antidrug antibodies
  • Median radiographic progression-free survival [ Time Frame: 12 months ]
    Assessed by Prostate Cancer Clinical Trials Working Group 3 criteria
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 29, 2018)
Exploratory Endpoint: Tumor expression of CD46 [ Time Frame: Through 1 month following last dose ]
Association between level of tumor expression of CD46 by immunohistochemistry (IHC) analysis with clinical outcomes
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official Title  ICMJE A Phase 1 Study of FOR46 Administered Every 21 Days in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Brief Summary

This study will test the safety and efficacy of FOR46 given every 21 days to patients with metastatic castration-resistant prostate cancer.

The name of the study drug involved in this study is: FOR46 for Injection (FOR46)

Detailed Description

This study is designed to evaluate the safety, tolerability and antitumor activity of FOR46 in patients with metastatic castration-resistant prostate cancer. This study will be conducted in two parts:

Dose escalation:

This part will evaluate increasing doses of FOR46 to identify the maximum tolerated dose (MTD). The first patient enrolled on the study will receive the lowest dose of FOR46. Once this dose is shown to be safe, a second patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD is reached.

Dose expansion:

This part of the study will further evaluate the safety, tolerability and antitumor activity of FOR46 at a dose shown to be safe in the dose escalation part of the study. Patients will be enrolled into 1 of 2 groups, based on histology.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Following completion of the dose escalation phase of the study and determination of a recommended phase 2 dose, patients will be enrolled into a dose expansion cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer Metastatic
Intervention  ICMJE Drug: FOR46
FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46
Study Arms  ICMJE
  • Experimental: FOR46 (Dose Escalation)
    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.
    Intervention: Drug: FOR46
  • Experimental: FOR46 (Dose Expansion)
    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.
    Intervention: Drug: FOR46
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 20, 2020
Estimated Primary Completion Date April 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male ≥ 18 years of age
  • Has histologically confirmed prostate cancer that is metastatic and has progressed as defined by PCWG3 criteria during or after treatment with at least 1 ASI (eg, abiraterone, enzalutamide, apalutamide), or another second-generation anti-androgen or cytochrome P450 (CYP)17A1 inhibitor, with the most recent ASI administered in the castration-resistant setting
  • 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
  • ECOG performance status of 0 or 1
  • Adequate hematologic, renal and hepatic function
  • Males with female partners of childbearing potential must agree to use 2 effective methods of contraception
  • Patients must provide signed informed consent
  • Patients enrolled into the dose expansion phase must be willing to undergo a metastatic tumor biopsy or has tissue available from a prior post-castration resistant tumor biopsy

Exclusion Criteria:

  • Persistent clinically significant toxicities from previous anticancer therapy
  • Prior treatment with cytotoxic chemotherapy for mCRPC (chemotherapy in the hormone-sensitive setting is allowed if > 6 months before study entry)
  • Has received external-beam radiation or systemic anticancer therapy within 14 days before first dose of FOR46
  • Has received treatment with an investigational drug within 28 days before first dose of FOR46
  • Clinically significant cardiovascular disease
  • Uncontrolled, clinically significant pulmonary disease
  • Uncontrolled intercurrent illness
  • Requires medications that are strong inhibitors or strong inducers of CYP3A4
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrew Dorr, MD 858-504-1453 adorr414@me.com
Contact: Rocio Navarro 301-762-6100 ext 162 rnavarro@rrdintl.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03575819
Other Study ID Numbers  ICMJE FOR46-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fortis Therapeutics, Inc.
Study Sponsor  ICMJE Fortis Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrew Dorr, MD Fortis Therapeutics, Inc.
PRS Account Fortis Therapeutics, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP