Prostate Cancer Clinical Trial
Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC
Summary
A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and efficacy of prostate specific membrane antigen half-life extended bispecific T-cell engager acapatamab in subjects with metastatic castration-resistant prostate cancer, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
Full Description
This is a phase I, first-in-human study to evaluate the safety and tolerability of acapatamab; a half-life extended (HLE) bispecific T-cell engager (BiTE®) construct, alone and in combination with pembrolizumab, etanercept prophylaxis and cytochrome P450 (CYP) phenotyping cocktail in subjects with metastatic castration-resistant prostate cancer.
Eligibility Criteria
All Parts
Inclusion Criteria:
Subject has provided informed consent prior to initiation of any study specific activities/procedures
Subjects with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting
Subjects must have undergone bilateral orchiectomy or must be on continuous ADT with a gonadotropin releasing hormone (GnRH) agonist or antagonist
Total serum testosterone = 50 ng/dL or 1.7 nmol/L
Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
PSA level >/= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart
nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications
appearance of 2 or more new lesions in bone scan
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
Life expectancy >/= 6months
Exclusion Criteria:
Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue (agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for >/= 30 days prior to randomization are eligible
Prior PSMA-targeted therapy (subjects on prior therapy may be eligible if discussed with Amgen medical monitor prior to enrollment)
Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
Active autoimmune disease or any other diseases requiring immunosuppressive therapy while on study
Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose
Myocardial infarction, unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of acapatamab
Part 2 only:
Subjects on a prior PD-1 or PD-L1 inhibitor who experienced a Grade 3 or higher immune-related adverse event prior to first day of dosing
History or evidence of interstitial lung disease or active, non-infectious pneumonitis
Part 3 only:
- Evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product
Part 6 only:
Subjects are excluded from this cohort if any of the following additional criteria apply:
Subjects taking strong OAT3 inhibitors (eg, probenecid) or adjust the dosing to 1 mg PO QD.
Subjects with latent or active tuberculosis at screening
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There are 29 Locations for this study
Campbell California, 95008, United States
Duarte California, 91010, United States
Long Beach California, 90813, United States
Los Angeles California, 90095, United States
Atlanta Georgia, 30322, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
New Orleans Louisiana, 70112, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89169, United States
New York New York, 10065, United States
New York New York, 10065, United States
Dallas Texas, 75390, United States
Camperdown New South Wales, 2050, Australia
Randwick New South Wales, 2031, Australia
Parkville Victoria, 3050, Australia
Linz , 4020, Austria
Salzburg , 5020, Austria
Wien , 1020, Austria
Wien , 1090, Austria
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Vancouver British Columbia, V5Z 4, Canada
Villejuif Cedex , 94805, France
Kashiwa-shi Chiba, 277-8, Japan
Yokohama-shi Kanagawa, 232-0, Japan
Rotterdam , 3015 , Netherlands
Singapore , 11907, Singapore
Singapore , 16961, Singapore
Taoyuan , 33305, Taiwan
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