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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04631601
Other study ID # 20190505
Secondary ID 2020-001305-23
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date January 15, 2021
Est. completion date October 23, 2023

Study information

Verified date November 2023
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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 Acapatamab, in combination with enzalutamide, abiraterone, or the PD1 inhibitor AMG 404, AMG 404 monotherapy, as well as Acapatamab monotherapy, in participants with metastatic castration-resistant prostate cancer (mCRPC).


Recruitment information / eligibility

Status Terminated
Enrollment 65
Est. completion date October 23, 2023
Est. primary completion date October 23, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 99 Years
Eligibility 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 Acapatamab (or AMG 404 in Part 3) - No acute symptoms of COVID-19 disease within 10 days prior to first dose of Acapatamab (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 Subprotocol D only: Inclusion criteria - Subjects may have had novel hormonal therapies (NHT; eg, abiraterone, enzalutamide, apalutamide, or darolutamide) for prostate cancer, but no more than 1 NHT for metastatic prostate cancer - Ineligible for or refuse taxane therapy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Acapatamab
Acapatamab will be administered as an intravenous (IV) infusion.
Enzalutamide
Enzalutamide will be administered orally.
Abiraterone
Abiraterone will be administered orally.
AMG 404
AMG 404 will be administered as an intravenous (IV) infusion.

Locations

Country Name City State
Australia St Vincents Hospital Sydney Darlinghurst New South Wales
Denmark Rigshospitalet Kobenhavn O
Spain Clinica Universidad de Navarra Pamplona Navarra
Sweden Skanes universitetssjukhus Lund
Sweden Karolinska Universitetssjukhuset Solna Stockholm
Sweden Akademiska sjukhuset Uppsala
United Kingdom Royal Marsden Hospital Sutton
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Chicago Chicago Illinois
United States University of Texas Southwestern Medical Center Dallas Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Norton Cancer Institute Louisville Kentucky
United States University of California at Irvine Medical Center Orange California
United States University of California San Francisco Mission Bay Campus San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose exploration only: Number of participants who experience dose limiting toxicities (DLTs) The analysis of all endpoints, unless noted otherwise, will be conducted on the Safety Analysis Set defined as all subjects that are enrolled and receive at least 1 dose of Acapatamab. The analysis of dose-limiting toxicity (DLT) will be conducted on the DLT Analysis Set defined as all subjects that are enrolled and receive at least 1 dose of Acapatamab with an evaluable DLT endpoint. If a single subject experiences more than 1 DLT it will be counted as 1.
The DLT endpoint is evaluable if either:
1) the subject experiences a DLT; or 2) the subject does not experience a DLT after receiving all planned doses within the 28-day DLT window in cycle 1.
Up to 3 years
Primary Number of participants who experience one or more treatment-emergent adverse events (TEAEs) Up to 3 years
Primary Number of participants who experience one or more treatment-related adverse events Up to 3 years
Primary Number of participants who experience a clinically significant change in vital signs Up to 3 years
Primary Number of participants who experience a clinically significant change in clinical laboratory tests Up to 3 years
Secondary Objective response rate per response evaluation criteria in solid tumors (RECIST) 1.1 with prostate cancer working group 3 (PCWG3) modifications Up to 3 years
Secondary Number of participants who experience circulating tumor cell (CTC) response Up to 3 years
Secondary Number of participants who experience prostate-specific antigen (PSA) response rate Up to 3 years
Secondary Duration of response Up to 3 years
Secondary Overall survival (OS) Up to 3 years
Secondary Progression-free survival Up to 3 years
Secondary Time to progression Up to 3 years
Secondary Time to subsequent therapy Up to 3 years
Secondary Maximum plasma concentration (Cmax) Up to 3 years
Secondary Minimum plasma concentration (Cmin) Up to 3 years
Secondary Area under the concentration-time curve (AUC) Up to 3 years
Secondary Accumulation ratio based on area under the concentration-time curve (AUC) Up to 3 years
Secondary Half-life (t1/2) Up to 3 years
Secondary Change from baseline in prostate-specific membrane antigen (PSMA)-positive tumor burden assessed using gallium (GA) 68-labelled PSMA-11 positron emission tomography/computed tomography (PET/CT) Baseline up to 3 years
Secondary Change from baseline in prostate-specific membrane antigen (PSMA)-negative disease burden assessed using 18F-fluorodeoxyglucose (F-FDG) positron emission tomography/computed tomography (PET/CT) Baseline to 3 years
Secondary Time to symptomatic skeletal events Up to 3 years
Secondary Concentration of alkaline phosphatase Up to 3 years
Secondary Concentration of lactate dehydrogenase (LDH) Up to 3 years
Secondary Concentration of hemoglobin Up to 3 years
Secondary Neutrophil-to-lymphocyte ratio Up to 3 years
Secondary Concentration of N-telopeptide in the urine Up to 3 years
See also
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Terminated NCT05489991 - A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Phase 1/Phase 2
Active, not recruiting NCT05521412 - EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T Phase 1/Phase 2
Terminated NCT04556617 - PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Phase 1/Phase 2
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Recruiting NCT05005728 - XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT05762536 - Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC Phase 2