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

NCT03888612 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ARV-110-mCRPC-101
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 54

Brief 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).

Conditions

Prostate Cancer Metastatic

Keywords

Metastatic Prostate Cancer; Castrate-Resistant; Prostate Cancer; mCRPC; adenocarcinoma of the prostate; bavdegalutamide

Outcome Measures

Primary Outcomes (6)

• 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

  28 Days

• 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.

  28 Days

• 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.

  28 Days

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

  PSA response rate per PCWG3.

  12 Weeks

• 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.

  12 Weeks

• 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.

  12 Weeks

Secondary Outcomes (16)

• 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.

  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.

  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.

  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.

  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.

  12 Weeks

Study Arms (1)

ARV-110

EXPERIMENTAL

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

Interventions

ARV-110 DRUG

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

ARV-110

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arvinas Inc.: lead

Study Sites (54)

Clinical Trial Site

Los Angeles, California, 90095, United States

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Orange, California, 92868, United States

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San Francisco, California, 94158, United States

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New Haven, Connecticut, 06510, United States

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Altamonte Springs, Florida, 32701, United States

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Bonita Springs, Florida, 34135, United States

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Bradenton, Florida, 34211, United States

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Brandon, Florida, 33511, United States

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Cape Coral, Florida, 33939, United States

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Clearwater, Florida, 33761, United States

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Daytona Beach, Florida, 32117, United States

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Fleming Island, Florida, 32003, United States

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Fort Myers, Florida, 33908, United States

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Gainesville, Florida, 32605, United States

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Largo, Florida, 33770, United States

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Lecanto, Florida, 34461, United States

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Naples, Florida, 34102, United States

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New Port Richey, Florida, 34655, United States

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Ocala, Florida, 34474, United States

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Orange City, Florida, 32763, United States

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Orlando, Florida, 32806, United States

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Port Charlotte, Florida, 33980, United States

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Sarasota, Florida, 34236, United States

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Spring Hill, Florida, 34608, United States

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St. Petersburg, Florida, 33705, United States

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Stuart, Florida, 34994, United States

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Tampa, Florida, 33607, United States

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Tavares, Florida, 32778, United States

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The Villages, Florida, 32159, United States

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Venice, Florida, 34292, United States

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Vero Beach, Florida, 32960, United States

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Wellington, Florida, 33414, United States

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West Palm Beach, Florida, 33401, United States

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Winter Park, Florida, 32792, United States

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Chicago, Illinois, 60611, United States

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New Orleans, Louisiana, 70112, United States

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Boston, Massachusetts, 02114, United States

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Detroit, Michigan, 48201, United States

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Omaha, Nebraska, 68130, United States

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Las Vegas, Nevada, 89169, United States

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New York, New York, 10065, United States

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Portland, Oregon, 97239, United States

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Dickson, Tennessee, 37055, United States

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Franklin, Tennessee, 37067, United States

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Gallatin, Tennessee, 37066, United States

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Hendersonville, Tennessee, 37075, United States

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Hermitage, Tennessee, 37076, United States

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Lebanon, Tennessee, 37090, United States

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Murfreesboro, Tennessee, 37129, United States

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Nashville, Tennessee, 37211, United States

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Shelbyville, Tennessee, 37160, United States

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Smyrna, Tennessee, 37167, United States

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Salt Lake City, Utah, 84112, United States

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Charlottesville, Virginia, 22903, United States

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Related Publications (1)

• 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.

  PMID: 39670468 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: March 1, 2019
• Primary Completion: April 29, 2024
• Study Completion: January 27, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (54)