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Prostate Cancer MetastaticPhase 1/2mCRPCNCT03888612

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

A Phase 1/2 study testing ARV-110 in people with Prostate Cancer Metastatic, run by Arvinas Inc. at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
ARV-110
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
54 sitesUnited States
Study dates
1 Mar 2019to 27 Jan 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Clinical Trial Site

    Altamonte Springs, Florida, 32701

  • Clinical Trial Site

    Bonita Springs, Florida, 34135

  • Clinical Trial Site

    Boston, Massachusetts, 02114

  • Clinical Trial Site

    Bradenton, Florida, 34211

  • Clinical Trial Site

    Brandon, Florida, 33511

  • Clinical Trial Site

    Cape Coral, Florida, 33939

  • Clinical Trial Site

    Charlottesville, Virginia, 22903

  • Clinical Trial Site

    Chicago, Illinois, 60611

  • Clinical Trial Site

    Clearwater, Florida, 33761

  • Clinical Trial Site

    Daytona Beach, Florida, 32117

  • Clinical Trial Site

    Detroit, Michigan, 48201

  • Clinical Trial Site

    Dickson, Tennessee, 37055

  • Clinical Trial Site

    Fleming Island, Florida, 32003

  • Clinical Trial Site

    Fort Myers, Florida, 33908

  • Clinical Trial Site

    Franklin, Tennessee, 37067

  • Clinical Trial Site

    Gainesville, Florida, 32605

  • Clinical Trial Site

    Gallatin, Tennessee, 37066

  • Clinical Trial Site

    Hendersonville, Tennessee, 37075

  • Clinical Trial Site

    Hermitage, Tennessee, 37076

  • Clinical Trial Site

    Largo, Florida, 33770

  • Clinical Trial Site

    Las Vegas, Nevada, 89169

  • Clinical Trial Site

    Lebanon, Tennessee, 37090

  • Clinical Trial Site

    Lecanto, Florida, 34461

  • Clinical Trial Site

    Los Angeles, California, 90095

  • Clinical Trial Site

    Murfreesboro, Tennessee, 37129

  • Clinical Trial Site

    Naples, Florida, 34102

  • Clinical Trial Site

    Nashville, Tennessee, 37211

  • Clinical Trial Site

    New Haven, Connecticut, 06510

  • Clinical Trial Site

    New Orleans, Louisiana, 70112

  • Clinical Trial Site

    New Port Richey, Florida, 34655

  • Clinical Trial Site

    New York, New York, 10065

  • Clinical Trial Site

    Ocala, Florida, 34474

  • Clinical Trial Site

    Omaha, Nebraska, 68130

  • Clinical Trial Site

    Orange, California, 92868

  • Clinical Trial Site

    Orange City, Florida, 32763

  • Clinical Trial Site

    Orlando, Florida, 32806

  • Clinical Trial Site

    Port Charlotte, Florida, 33980

  • Clinical Trial Site

    Portland, Oregon, 97239

  • Clinical Trial Site

    Salt Lake City, Utah, 84112

  • Clinical Trial Site

    San Francisco, California, 94158

  • Clinical Trial Site

    Sarasota, Florida, 34236

  • Clinical Trial Site

    Shelbyville, Tennessee, 37160

  • Clinical Trial Site

    Smyrna, Tennessee, 37167

  • Clinical Trial Site

    Spring Hill, Florida, 34608

  • Clinical Trial Site

    St. Petersburg, Florida, 33705

  • Clinical Trial Site

    Stuart, Florida, 34994

  • Clinical Trial Site

    Tampa, Florida, 33607

  • Clinical Trial Site

    Tavares, Florida, 32778

  • Clinical Trial Site

    The Villages, Florida, 32159

  • Clinical Trial Site

    Venice, Florida, 34292

  • Clinical Trial Site

    Vero Beach, Florida, 32960

  • Clinical Trial Site

    Wellington, Florida, 33414

  • Clinical Trial Site

    West Palm Beach, Florida, 33401

  • Clinical Trial Site

    Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: 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).

Being tested
ARV-110
Keywords
Metastatic Prostate Cancer, Castrate-Resistant, Prostate Cancer, mCRPC, adenocarcinoma of the prostate, bavdegalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARV-110Drug

    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

Study groups in NCT03888612
Study groupRoleWhat they receive
ARV-110ExperimentalPart 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
Receives: Drug: ARV-110

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Incidence of Dose Limiting Toxicities of ARV-110

    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

    Measured: 28 Days

  2. Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110

    Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.

    Measured: 28 Days

  3. Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

    Measured: 28 Days

  4. Part B: Measurement of PSA response rate per PCWG3 accessing anti-tumor activity of ARV-110

    PSA response rate per PCWG3.

    Measured: 12 Weeks

  5. Part B: Measurement of overall RECIST response rate accessing the anti-tumor activity of ARV-110

    Overall RECIST response rate in patients with measurable disease at baseline.

    Measured: 12 Weeks

  6. Part B: To evaluate the clinical anti-tumor activity of ARV-110 in patients with mCRPC

    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.

    Measured: 12 Weeks

Secondary outcomes (16)

  1. 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.

    The anti-tumor activity of ARV-110 will be assessed by evaluating the overall PSA response per PCWG3.

    Measured: 12 Weeks

  2. 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.

    The anti-tumor activity of ARV-110 will be assessed by evaluating the overall RECIST response rate.

    Measured: 12 Weeks

  3. 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.

    The anti-tumor activity of ARV-110 will be assessed by evaluating the time to event progression free survival.

    Measured: 12 Weeks

  4. 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.

    The anti-tumor activity of ARV-110 will be assessed by evaluating the duration of response.

    Measured: 12 Weeks

  5. 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.

    The anti-tumor activity of ARV-110 will be assessed by evaluating the time to progression.

    Measured: 12 Weeks

  6. 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.

    The anti-tumor activity of ARV-110 will be assessed by evaluating the overall survival.

    Measured: 12 Weeks

  7. Part A: Concentration-time curve (AUC) for single and multiple dose of ARV-110

    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).

    Measured: 28 Days

  8. Part A: Maximum concentration (Cmax) for single and multiple dose of ARV-110

    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).

    Measured: 28 Days

  9. Part A: Minimum concentration (Cmin) for single and multiple dose of ARV-110

    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).

    Measured: 28 Days

  10. Part A: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110

    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)

    Measured: 28 Days

  11. Part B: Concentration-time curve (AUC) for single and multiple dose of ARV-110

    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).

    Measured: 28 Days

  12. Part B: Maximum concentration (Cmax) for single and multiple dose of ARV-110

    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).

    Measured: 28 Days

  13. Part B: Minimum concentration (Cmin) for single and multiple dose of ARV-110

    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).

    Measured: 28 Days

  14. Part B: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110

    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)

    Measured: 28 Days

  15. Part B: Duration of response

    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.

    Measured: 12 Weeks

  16. Part B: Overall survival

    Time interval from the date of first ARV-110 dose to the date of death due to any cause.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start1 Mar 2019
  3. Primary completion29 Apr 2024
  4. Study completion27 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03888612
Sponsor's protocol ID
ARV-110-mCRPC-101
Acronym
mCRPC
Status last verified
Mar 2025
First submitted
21 Mar 2019
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Snyder LB, Neklesa TK, Willard RR, Gordon DA, Pizzano J, Vitale N, Robling K, Dorso MA, Moghrabi W, Landrette S, Gedrich R, Lee SH, Taylor ICA, Houston JG. Preclinical Evaluation of Bavdegalutamide (ARV-110), a Novel PROteolysis TArgeting Chimera Androgen Receptor Degrader. Mol Cancer Ther. 2025 Apr 2;24(4):511-522. doi: 10.1158/1535-7163.MCT-23-0655.

    PubMed 39670468

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ARV-110 in people with Prostate Cancer Metastatic, run by Arvinas Inc. at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence of Dose Limiting Toxicities of ARV-110 (time frame: 28 Days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03888612, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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