A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Prostate Cancer Metastatic
In brief
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.
Key facts
- Study ID
- NCT05067140
- Run by
- Novartis Pharmaceuticals
- People needed
- 152
- Starts
- 2021-09-02
- Expected to finish
- 2027-05-25
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Trial Site — Duarte, California, United States
- Clinical Trial Site — Fresno, California, United States
- Clinical Trial Site — La Jolla, California, United States
- Clinical Trial Site — Orange, California, United States
- Clinical Trial Site — Santa Monica, California, United States
- Clinical Trial Site — New Haven, Connecticut, United States
- Clinical Trial Site — Washington D.C., District of Columbia, United States
- Clinical Trial Site — Lake Mary, Florida, United States
- Clinical Trial Site — Chicago, Illinois, United States
- Clinical Trial Site — New Orleans, Louisiana, United States
- Clinical Trial Site — Baltimore, Maryland, United States
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Detroit, Michigan, United States
- Clinical Trial Site — Buffalo, New York, United States
- Clinical Trial Site — New York, New York, United States
- Clinical Trial Site — Philadelphia, Pennsylvania, United States
- Clinical Trial Site — Pittsburgh, Pennsylvania, United States
- Clinical Trial Site — Myrtle Beach, South Carolina, United States
- Clinical Trial Site — Nashville, Tennessee, United States
- Clinical Trial Site — San Antonio, Texas, United States
- Clinical Trial Site — Charlottesville, Virginia, United States
- Clinical Trial Site — Fairfax, Virginia, United States
- Clinical Trial Site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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