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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 : Not yet recruiting
First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Fortis Therapeutics, Inc.

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)


Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: FOR46 Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: A Phase 1 Study of FOR46 Administered Every 21 Days in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : October 20, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.
Drug: FOR46
FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46

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.
Drug: FOR46
FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46




Primary Outcome Measures :
  1. Occurrence of toxicity [ Time Frame: Through 1 month following last dose ]
    Type, incidence, severity, seriousness, and relatedness of adverse events.

  2. 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

  3. 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)


Secondary Outcome Measures :
  1. Characterize FOR46 plasma concentration [ Time Frame: Through 1 month following last dose ]
    FOR46 maximum plasma concentration

  2. Characterize the FOR46 area under the curve [ Time Frame: Through 1 month following last dose ]
    FOR46 area under the plasma concentration-time curve

  3. Characterize FOR46 elimination [ Time Frame: Through 1 month following last dose ]
    FOR46 elimination half-life

  4. Antidrug Antibodies [ Time Frame: Through 1 month following last dose ]
    Change from baseline in serum levels of antidrug antibodies

  5. Median radiographic progression-free survival [ Time Frame: 12 months ]
    Assessed by Prostate Cancer Clinical Trials Working Group 3 criteria


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575819


Contacts
Contact: Andrew Dorr, MD 858-504-1453 adorr414@me.com
Contact: Kimberly Marshall, BSN 301-762-6100 ext 108 kmarshall@rrdintl.com

Sponsors and Collaborators
Fortis Therapeutics, Inc.
Investigators
Study Director: Andrew Dorr, MD Fortis Therapeutics, Inc.

Responsible Party: Fortis Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03575819     History of Changes
Other Study ID Numbers: FOR46-001
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fortis Therapeutics, Inc.:
castration-resistant
androgen-signaling blockade progression

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases