Summary

Eligibility
for males ages 18-99 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).

Official Title

A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)

Details

This is a master protocol designed to evaluate the safety, tolerability, and maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) and efficacy of AMG 160, in combination with enzalutamide, abiraterone, or the PD1 inhibitor AMG 404 as well as AMG 404 monotherapy, in participants with metastatic castration-resistant prostate cancer (mCRPC).

Keywords

Metastatic Castration-resistant Prostate Cancer AMG 160 HALF-LIFE EXTENDED (HLE) BITE mCRPC 68 Gallium (68Ga)-prostate-specific membrane antigen (PSMA)-11 positron emission tomography(PET)/computed tomography (CT) and 18 F-fluorodeoxyglucose (FDG) PET/CT based response evaluation Bispecific T cell Engager BITE Prostatic Neoplasms Androgens Androgen Receptor Antagonists Enzalutamide Abiraterone AMG 404 AMG 160 and Enzalutamide: Dose Exploration AMG 160 and Enzalutamide: Dose Expansion AMG 160 and Abiraterone: Dose Exploration AMG 160 and Abiraterone: Dose Expansion AMG 160 and AMG 404: Dose Exploration AMG 160 and AMG 404: Dose Expansion AMG 404 Monotherapy

Eligibility

For males ages 18-99

All parts

Inclusion Criteria:

  • ≥ 18 years of age (or legal adult age within country)
  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures
  • Subjects with mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate
  • Subjects should have undergone bilateral orchiectomy or should be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist (testosterone ≤ 50 ng/dL (or 1.7 nmol/L))

Exclusion Criteria:

  • Central nervous system (CNS) metastases or leptomeningeal disease
  • History or presence of clinically relevant CNS pathology
  • Confirmed history or current autoimmune disease or other diseases requiring permanent immunosuppressive therapy
  • Myocardial infarction, uncontrolled hypertension, unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months
  • Prior treatment with a taxane for mCRPC
  • Major surgery and/or Radiation within 4 weeks
  • History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with medical monitor and meeting the following criteria:
  • Negative test for SARS-CoV-2 RNA by real time polymerase chain reaction (RT-PCR) within 72 hours of first dose of AMG 160 (or AMG 404 in Part 3)
  • No acute symptoms of COVID-19 disease within 10 days prior to first dose of AMG 160 (or AMG 404 in Part 3) (counted from day of positive test for asymptomatic subjects)

Prior/Concurrent Clinical Study Experience

  • Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded with the exception of investigational scans.

Subprotocol A only:

Inclusion criteria

• Subjects planning to receive enzalutamide for the first time for mCRPC

Exclusion criteria

  • Use of strong CYP2C8 inhibitors or strong CYP3A4 inducers
  • Use of narrow therapeutic index drugs that are substrates of CYP3A4, CYP2C9 or CYP2C19

Subprotocol B only:

Inclusion criteria

  • Subjects planning to receive abiraterone for the first time for mCRPC Exclusion criteria
  • Baseline moderate and severe hepatic impairment (Child-Pugh Class B and C)
  • Presence of uncontrolled hypertension, hypokalemia, or fluid retention
  • History or presence of adrenocortical insufficiency
  • Use of concomitant medications that are sensitive substrates for CYP2D6 with a narrow therapeutic index
  • Use of strong CYP3A4 inducers

Subprotocol C only:

Inclusion criteria

  • Subjects who are refractory to a novel antiandrogen therapy. Subjects must be ineligible for or refuse taxane therapy.
  • 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, and/or appearance of 2 or more new lesions in bone scan Exclusion criteria
  • History or evidence of interstitial lung disease or active, non-infectious pneumonitis
  • 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 dose

Locations

  • University of California San Francisco Mission Bay Campus accepting new patients
    San Francisco California 94158 United States
  • University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
ID
NCT04631601
Phase
Phase 1/2
Study Type
Interventional
Last Updated