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NCT Number: NCT05067140

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Metastatic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Trial Site, Duarte, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARV-766 Part A&B

Drug

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.

ARV-766 + Abiraterone Part C&D

Drug

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 names: Corticosteroid and ADT

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 5, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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