Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

March 28, 2025 updated by: Arvinas Inc.

A Phase 1/2, Open-label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer

Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Clinical Trial Site
      • Orange, California, United States, 92868
        • Clinical Trial Site
      • San Francisco, California, United States, 94158
        • Clinical Trial Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Clinical Trial Site
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Clinical Trial Site
      • Bonita Springs, Florida, United States, 34135
        • Clinical Trial Site
      • Bradenton, Florida, United States, 34211
        • Clinical Trial Site
      • Brandon, Florida, United States, 33511
        • Clinical Trial Site
      • Cape Coral, Florida, United States, 33939
        • Clinical Trial Site
      • Clearwater, Florida, United States, 33761
        • Clinical Trial Site
      • Daytona Beach, Florida, United States, 32117
        • Clinical Trial Site
      • Fleming Island, Florida, United States, 32003
        • Clinical Trial Site
      • Fort Myers, Florida, United States, 33908
        • Clinical Trial Site
      • Gainesville, Florida, United States, 32605
        • Clinical Trial Site
      • Largo, Florida, United States, 33770
        • Clinical Trial Site
      • Lecanto, Florida, United States, 34461
        • Clinical Trial Site
      • Naples, Florida, United States, 34102
        • Clinical Trial Site
      • New Port Richey, Florida, United States, 34655
        • Clinical Trial Site
      • Ocala, Florida, United States, 34474
        • Clinical Trial Site
      • Orange City, Florida, United States, 32763
        • Clinical Trial Site
      • Orlando, Florida, United States, 32806
        • Clinical Trial Site
      • Port Charlotte, Florida, United States, 33980
        • Clinical Trial Site
      • Saint Petersburg, Florida, United States, 33705
        • Clinical Trial Site
      • Sarasota, Florida, United States, 34236
        • Clinical Trial Site
      • Spring Hill, Florida, United States, 34608
        • Clinical Trial Site
      • Stuart, Florida, United States, 34994
        • Clinical Trial Site
      • Tampa, Florida, United States, 33607
        • Clinical Trial Site
      • Tavares, Florida, United States, 32778
        • Clinical Trial Site
      • The Villages, Florida, United States, 32159
        • Clinical Trial Site
      • Venice, Florida, United States, 34292
        • Clinical Trial Site
      • Vero Beach, Florida, United States, 32960
        • Clinical Trial Site
      • Wellington, Florida, United States, 33414
        • Clinical Trial Site
      • West Palm Beach, Florida, United States, 33401
        • Clinical Trial Site
      • Winter Park, Florida, United States, 32792
        • Clinical Trial Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Clinical Trial Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Clinical Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Clinical Trial Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Clinical Trial Site
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Clinical Trial Site
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Clinical Trial Site
    • New York
      • New York, New York, United States, 10065
        • Clinical Trial Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Clinical Trial Site
    • Tennessee
      • Dickson, Tennessee, United States, 37055
        • Clinical Trial Site
      • Franklin, Tennessee, United States, 37067
        • Clinical Trial Site
      • Gallatin, Tennessee, United States, 37066
        • Clinical Trial Site
      • Hendersonville, Tennessee, United States, 37075
        • Clinical Trial Site
      • Hermitage, Tennessee, United States, 37076
        • Clinical Trial Site
      • Lebanon, Tennessee, United States, 37090
        • Clinical Trial Site
      • Murfreesboro, Tennessee, United States, 37129
        • Clinical Trial Site
      • Nashville, Tennessee, United States, 37211
        • Clinical Trial Site
      • Shelbyville, Tennessee, United States, 37160
        • Clinical Trial Site
      • Smyrna, Tennessee, United States, 37167
        • Clinical Trial Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Clinical Trial Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Part A:

  • Patients must be male and at least 18 years of age at the time of signing the informed consent.
  • Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate.
  • Patients must have progressed on at least 2 prior approved systemic therapies for CRPC (at least one must be abiraterone or enzalutamide).
  • Patients with progressive mCRPC
  • Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).

Part B:

  • Patients must be male and at least 18 years of age at the time of signing the informed consent.
  • Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate.
  • Patients must have received at least one but no more than two prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone) for CRPC.
  • Patients must have received no more than one prior chemotherapy regimen in each of the following settings: castrate sensitive and castrate resistant prostate cancer.
  • Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).

Part B - Phase 2 Expansion Cohort Subgroup 4

  • Patient has received only one prior AR second generation therapy (e.g., abiraterone or enzalutamide) either as treatment for CSPC or CRPC and no more than 1 regimen in CRPC setting.
  • No prior chemotherapy

Exclusion Criteria:

Part A:

  • Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses)
  • Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
  • Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study
  • Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug.

Part B:

  • Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses)
  • Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
  • Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study
  • Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARV-110

Part A: Oral tablet(s), once or twice daily in 28 day cycles

Part B: Oral tablet(s), once or twice daily in 28 day cycles
Drug: ARV-110

Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment

Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Incidence of Dose Limiting Toxicities of ARV-110
Time Frame: 28 Days
First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug
28 Days
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110
Time Frame: 28 Days
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
28 Days
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110
Time Frame: 28 Days
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
28 Days
Part B: Measurement of PSA response rate per PCWG3 accessing anti-tumor activity of ARV-110
Time Frame: 12 Weeks
PSA response rate per PCWG3.
12 Weeks
Part B: Measurement of overall RECIST response rate accessing the anti-tumor activity of ARV-110
Time Frame: 12 Weeks
Overall RECIST response rate in patients with measurable disease at baseline.
12 Weeks
Part B: To evaluate the clinical anti-tumor activity of ARV-110 in patients with mCRPC
Time Frame: 12 Weeks
To evaluate the clinical anti-tumor activity (PSA response rate per PCWG3, Overall RECIST RR, rPFS, and PFS) of ARV-110 in patients with mCRPC in different subgroups of patients with mCRPC with predefined tumor genomic and molecular profiles or based on prior therapy.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Anti-tumor activity based on the overall PSA response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
Time Frame: 12 Weeks
The anti-tumor activity of ARV-110 will be assessed by evaluating the overall PSA response per PCWG3.
12 Weeks
Part A: Anti-tumor activity based on the overall RECIST response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
Time Frame: 12 Weeks
The anti-tumor activity of ARV-110 will be assessed by evaluating the overall RECIST response rate.
12 Weeks
Part A: Anti-tumor activity based on the progression free survival in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
Time Frame: 12 Weeks
The anti-tumor activity of ARV-110 will be assessed by evaluating the time to event progression free survival.
12 Weeks
Part A: Anti-tumor activity based on the duration of response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
Time Frame: 12 Weeks
The anti-tumor activity of ARV-110 will be assessed by evaluating the duration of response.
12 Weeks
Part A: Anti-tumor activity based on the time to progression in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
Time Frame: 12 Weeks
The anti-tumor activity of ARV-110 will be assessed by evaluating the time to progression.
12 Weeks
Part A: Anti-tumor activity based on the overall survival in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
Time Frame: 12 Weeks
The anti-tumor activity of ARV-110 will be assessed by evaluating the overall survival.
12 Weeks
Part A: Concentration-time curve (AUC) for single and multiple dose of ARV-110
Time Frame: 28 Days
PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).
28 Days
Part A: Maximum concentration (Cmax) for single and multiple dose of ARV-110
Time Frame: 28 Days
PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter maximum concentration (Cmax).
28 Days
Part A: Minimum concentration (Cmin) for single and multiple dose of ARV-110
Time Frame: 28 Days
PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter minimum concentration (Cmin).
28 Days
Part A: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110
Time Frame: 28 Days
PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
28 Days
Part B: Concentration-time curve (AUC) for single and multiple dose of ARV-110
Time Frame: 28 Days
PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).
28 Days
Part B: Maximum concentration (Cmax) for single and multiple dose of ARV-110
Time Frame: 28 Days
PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter maximum concentration (Cmax).
28 Days
Part B: Minimum concentration (Cmin) for single and multiple dose of ARV-110
Time Frame: 28 Days
PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter minimum concentration (Cmin).
28 Days
Part B: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110
Time Frame: 28 Days
PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
28 Days
Part B: Duration of response
Time Frame: 12 Weeks
From the date of first confirmed best overall response of CR or PR to the date of first progression per RECIST 1.1 or PCWG3, or death due to any cause without evidence of radiographic progression, whichever occurs first.
12 Weeks
Part B: Overall survival
Time Frame: 12 Weeks
Time interval from the date of first ARV-110 dose to the date of death due to any cause.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arvinas Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

January 27, 2025

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

March 22, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARV-110-mCRPC-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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