Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC

Stopped early · Phase 1

Conditions studied: Metastatic Castration-resistant Prostate Cancer, Prostate Cancer

In brief

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).

Key facts

Study ID

NCT03792841

Run by

Amgen

People needed

212

Starts

2019-02-05

Expected to finish

2023-06-29

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• El Camino Hospital — Campbell, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• City of Hope at Long Beach Elm — Long Beach, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Washington University — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Chris OBrien Lifehouse — Camperdown, New South Wales, Australia
• Scientia Clinical Research Ltd — Randwick, New South Wales, Australia
• Peter MacCallum Cancer Centre — Parkville, Victoria, Australia
• Ordensklinikum Linz Elisabethinen — Linz, Austria
• Landeskrankenhaus Salzburg — Salzburg, Austria
• Krankenhaus der Barmherzigen Brueder Wien — Vienna, Austria
• Universitaetsklinikum Allgemeines Krankenhaus Wien — Vienna, Austria
• Universite Catholique de Louvain Cliniques Universitaires Saint Luc — Brussels, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• BC Cancer Vancouver — Vancouver, British Columbia, Canada
• Institut Gustave Roussy — Villejuif, France
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan

Full record on ClinicalTrials.gov

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