A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer

• ClinicalTrials.gov Identifier: NCT05067140
• Recruitment Status: Recruiting
• First Posted: October 5, 2021
• Last Update Posted: April 5, 2024
• Sponsor: Arvinas Androgen Receptor, Inc.
• Information provided by (Responsible Party): Arvinas Inc. ( Arvinas Androgen Receptor, Inc. )

Tracking Information

• First Submitted Date: September 23, 2021
• First Posted Date: October 5, 2021
• Last Update Posted Date: April 5, 2024
• Actual Study Start Date: September 2, 2021
• Estimated Primary Completion Date: December 6, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 30, 2023)

• Part A: Incidence of Dose Limiting Toxicities of ARV-766 [ Time Frame: 28 Days ]
  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 [ Time Frame: 28 Days ]
  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 [ Time Frame: 28 Days ]
  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 [ Time Frame: 12 Weeks ]
  Evaluate PSA in patients with mCRPC in both dose groups
• Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination [ Time Frame: 28 Days ]
  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 C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination [ Time Frame: 28 Days ]
  Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
• Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination [ Time Frame: 28 Days ]
  Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
• Part D: To evaluate the clinical anti-tumor activity of ARV-766 / abiraterone combination in patients with NHA-naïve mPC [ Time Frame: 12 Weeks ]
  Evaluate PSA in patients with NHA-naïve mPC

Original Primary Outcome Measures (submitted: October 4, 2021)

• Incidence of Dose Limiting Toxicities of ARV-766 [ Time Frame: 28 Days ]
  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
• Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 [ Time Frame: 28 Days ]
  Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
• Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 [ Time Frame: 28 Days ]
  Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
• 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 Monotherapy and in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
• Brief Summary: A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth alone or in combination with abiraterone in men with metastatic prostate cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer Metastatic

Intervention

• Drug: ARV-766 Part A&B

  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.

  Part B: Oral tablet(s) once daily in 28 day cycles.

• Drug: ARV-766 + Abiraterone Part C&D

  Part C: Daily oral combination dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.

  Part D: Combination administered once daily in 28 day cycles.

  Parts C&D: Participants will also receive concomitant corticosteroid and ADT therapy of investigator choice/patient preference

  Other Name: Corticosteroid and ADT

Study Arms

• Experimental: ARV-766
  Oral tablets, once daily in 28 day cycles
  Intervention: Drug: ARV-766 Part A&B
• Experimental: ARV-766 + Abiraterone
  Oral tablets, once daily in 28 day cycles
  Intervention: Drug: ARV-766 + Abiraterone Part C&D

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 30, 2023): 220
• Original Estimated Enrollment (submitted: October 4, 2021): 60
• Estimated Study Completion Date: June 27, 2026
• Estimated Primary Completion Date: December 6, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Part A,B,C and D:

• Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
• 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).
• Progressive mCRPC

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.
• Progressive mCRPC

Part C & D:

• Metastatic castration resistant or sensitive prostate cancer with radiographic evidence of metastatic disease

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.

Part C and D

• Prior treatment with a second generation NHA

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Arvinas Androgen Receptor, Inc.; 475-345-3374; clinicaltrialsARV-766@arvinas.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05067140
• Other Study ID Numbers: ARV-766-mCRPC-101
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Arvinas Inc. ( Arvinas Androgen Receptor, Inc. )
• Original Responsible Party: Same as current
• Current Study Sponsor: Arvinas Androgen Receptor, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Arvinas Inc.
• Verification Date: April 2024