Open Actively Recruiting

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

About

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 metastatic castration-resistant prostate cancer, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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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Study Stats
Protocol No.
19-000046
Category
Oncology
Urology
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03792841
For detailed technical eligibility, visit ClinicalTrials.gov.