Status:
TERMINATED
Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC
Lead Sponsor:
Amgen
Conditions:
Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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 metas...
Detailed 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 pem...
Eligibility Criteria
Inclusion
- All Parts
- 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
- 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
Key Trial Info
Start Date :
February 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT03792841
Start Date
February 5 2019
End Date
June 29 2023
Last Update
October 16 2025
Active Locations (30)
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1
El Camino Hospital
Campbell, California, United States, 95008
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
City of Hope at Long Beach Elm
Long Beach, California, United States, 90813
4
University of California Los Angeles
Los Angeles, California, United States, 90095