Description:
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)
Title
- Brief Title: A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Official Title: A Phase 1 Study of FOR46 Administered Every 21 Days in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Clinical Trial IDs
- ORG STUDY ID:
FOR46-001
- NCT ID:
NCT03575819
Conditions
- Prostate Cancer Metastatic
Interventions
Drug | Synonyms | Arms |
---|
FOR46 | | FOR46 (Dose Escalation) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
FOR46 (Dose Escalation) | Experimental | 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. | |
FOR46 (Dose Expansion) | Experimental | 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. | |
Eligibility 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 have prostate carcinoma without
histologic evidence of small-cell/neuroendocrine carcinoma features on prior biopsy or
must have unequivocal histologic evidence of small-cell/neuroendocrine prostate
carcinoma (pure or mixed). Patients with treatment-emergent small-cell neuroendocrine
cancer (pure or mixed) may have received no more than on prior chemotherapy regimen
for mCRPC
- 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
- Has NCI CTCAE Grade ≥ 2 peripheral neuropathy from any etiology or has a genetic
disorder that is associated with peripheral neuropathy even without current
neuropathic manifestations
- 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
- Has had a major surgical procedure within 28 days before administration of FOR46 dose
- Clinically significant cardiovascular disease
- Uncontrolled, clinically significant pulmonary disease
- Has a history of brain or leptomeningeal metastases.
- Uncontrolled intercurrent illness
- Has a known positive status for HIV or either active/chronic hepatitis B/C
- Requires medications that are strong inhibitors or strong inducers of CYP3A4
- [Dose escalation only] Has a history of episodic atrial fibrillation or flutter
(patients with chronic atrial fibrillation are not excluded)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Occurrence of toxicity |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | Type, incidence, severity, seriousness, and relatedness of adverse events. |
Secondary Outcome Measures
Measure: | Characterize FOR46 plasma concentration |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | FOR46 maximum plasma concentration |
Measure: | Characterize the FOR46 area under the curve |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | FOR46 area under the plasma concentration-time curve |
Measure: | Characterize FOR46 elimination |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | FOR46 elimination half-life |
Measure: | Antidrug Antibodies |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | Change from baseline in serum levels of antidrug antibodies |
Measure: | Median radiographic progression-free survival |
Time Frame: | 12 months |
Safety Issue: | |
Description: | Assessed by Prostate Cancer Clinical Trials Working Group 3 criteria |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Fortis Therapeutics, Inc. |
Trial Keywords
- castration-resistant
- androgen-signaling blockade progression
Last Updated
August 19, 2021