A Study of ARV-766 Given by Mouth in Men With Metastatic Castration-resistant Prostate Cancer Who Have Progressed on Prior Approved Systemic Therapies
Primary Purpose
Prostate Cancer Metastatic
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARV-766 Part A
ARV-766 Part B
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring Metastatic Prostate Cancer, Castrate-Resistant, Prostate Cancer, mCRPC adenocarcinoma of prostate, Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms
Eligibility Criteria
Inclusion Criteria:
Part A and B:
- Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
- Progressive mCRPC
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Part A:
• Progression on at least 2 prior approved systemic therapies for metastatic prostate cancer (at least one must be a second-generation androgen inhibitor, e.g., abiraterone, enzalutamide, darolutamide, apalutamide).
Part B:
- Participants must have received at least one but no more than three prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone).
- Participants must have received no more than two prior chemotherapy regimens.
Exclusion Criteria:
Part A and B:
- Known symptomatic brain metastases requiring steroids (above physiologic replacement doses).
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery.
- Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow.
- Receipt of an investigational drug(s) within 4 weeks prior to anticipated first dose
- Systemic anti-cancer therapy within 2 weeks of first dose of study drug (except agents to maintain castrate status). For bicalutamide, mitomycin C, or nitrosoureas the exclusion period must be 6 weeks and for abiraterone 4 weeks.
Sites / Locations
- Clinical Trial Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ARV-766 Part A
ARV-766 Part B
Arm Description
Part A: Oral tablet(s), once or twice daily in 28 day cycles
Part B: Oral tablet(s) once daily in 28 days
Outcomes
Primary Outcome Measures
Part A: Incidence of Dose Limiting Toxicities of ARV-766
First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC
Evaluate PSA in patients with mCRPC in both dose groups
Secondary Outcome Measures
Full Information
NCT ID
NCT05067140
First Posted
September 23, 2021
Last Updated
July 18, 2023
Sponsor
Arvinas Androgen Receptor, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05067140
Brief Title
A Study of ARV-766 Given by Mouth in Men With Metastatic Castration-resistant Prostate Cancer Who Have Progressed on Prior Approved Systemic Therapies
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-766 in Patients With Metastatic Castration-Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
December 6, 2024 (Anticipated)
Study Completion Date
June 27, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arvinas Androgen Receptor, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth in men with metastatic castration-resistant prostate cancer who have progressed on prior approved systemic therapies
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic
Keywords
Metastatic Prostate Cancer, Castrate-Resistant, Prostate Cancer, mCRPC adenocarcinoma of prostate, Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARV-766 Part A
Arm Type
Experimental
Arm Description
Part A: Oral tablet(s), once or twice daily in 28 day cycles
Arm Title
ARV-766 Part B
Arm Type
Experimental
Arm Description
Part B: Oral tablet(s) once daily in 28 days
Intervention Type
Drug
Intervention Name(s)
ARV-766 Part A
Intervention Description
Part A: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.
Intervention Type
Drug
Intervention Name(s)
ARV-766 Part B
Intervention Description
Part B Participants will be randomized to receive daily oral dosage at one of two selected Phase 2 doses based on data from Part A
Primary Outcome Measure Information:
Title
Part A: Incidence of Dose Limiting Toxicities of ARV-766
Description
First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug
Time Frame
28 Days
Title
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766
Description
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
Time Frame
28 Days
Title
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766
Description
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
Time Frame
28 Days
Title
Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC
Description
Evaluate PSA in patients with mCRPC in both dose groups
Time Frame
12 Weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Part A and B:
Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
Progressive mCRPC
Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Part A:
• Progression on at least 2 prior approved systemic therapies for metastatic prostate cancer (at least one must be a second-generation androgen inhibitor, e.g., abiraterone, enzalutamide, darolutamide, apalutamide).
Part B:
Participants must have received at least one but no more than three prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone).
Participants must have received no more than two prior chemotherapy regimens.
Exclusion Criteria:
Part A and B:
Known symptomatic brain metastases requiring steroids (above physiologic replacement doses).
Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery.
Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow.
Receipt of an investigational drug(s) within 4 weeks prior to anticipated first dose
Systemic anti-cancer therapy within 2 weeks of first dose of study drug (except agents to maintain castrate status). For bicalutamide, mitomycin C, or nitrosoureas the exclusion period must be 6 weeks and for abiraterone 4 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arvinas Androgen Receptor, Inc.
Phone
475-345-3374
Email
clinicaltrialsARV-766@arvinas.com
Facility Information:
Facility Name
Clinical Trial Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19144
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trial Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Study of ARV-766 Given by Mouth in Men With Metastatic Castration-resistant Prostate Cancer Who Have Progressed on Prior Approved Systemic Therapies
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