Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Rahul Aggarwal, MD

Description

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)

Official Title

A Phase 1 Study of FOR46 Administered Every 21 Days in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Details

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.

Keywords

Prostate Cancer Metastatic castration-resistant androgen-signaling blockade progression Prostatic Neoplasms FOR46 FOR46 (Dose Escalation) FOR46 (Dose Expansion)

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • UCLA Institute of Urologic Oncology not yet accepting patients
    Los Angeles California 90095 United States

Lead Scientist

  • Rahul Aggarwal, MD
    I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. My clinical practice focuses on patients with advanced solid tumor malignancies with a particular emphasis on genitourinary malignancies including prostate, kidney, bladder, and testicular cancer. I serve as the Co-Leader for the GU Medical Oncology program at UCSF.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Fortis Therapeutics, Inc.
ID
NCT03575819
Phase
Phase 1
Study Type
Interventional
Last Updated