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

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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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
22-001945
Category
Prostate Cancer
Principal Investigator
Contact
SANDY HERNANDEZ CENTENO
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT05067140
For detailed technical eligibility, visit ClinicalTrials.gov.