Study Description
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.
Interventions
ARV-766 + Abiraterone Part C&D
ARV-766 Part A&B
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
Clinical Trial Site
Recruiting
Orange,California,92868,United States
Clinical Trial Site
Recruiting
Myrtle Beach,South Carolina,29572,United States
Clinical Trial Site
Recruiting
Boston,Massachusetts,02114,United States
Clinical Trial Site
Recruiting
Santa Monica,California,90404,United States
Clinical Trial Site
Recruiting
Nashville,Tennessee,37203,United States
Clinical Trial Site
Recruiting
Detroit,Michigan,48201,United States
Clinical Trial Site
Recruiting
New Haven,Connecticut,06510,United States
Clinical Trial Site
Recruiting
San Antonio,Texas,78229,United States
Clinical Trial Site
Recruiting
Buffalo,New York,14203,United States
Clinical Trial Site
Recruiting
Lake Mary,Florida,32746,United States
Clinical Trial Site
Recruiting
Charlottesville,Virginia,22908,United States
Clinical Trial Site
Recruiting
Duarte,California,91010,United States
Clinical Trial Site
Recruiting
New York,New York,10065,United States
Clinical Trial Site
Recruiting
Chicago,Illinois,60611,United States
Clinical Trial Site
Recruiting
Fairfax,Virginia,22031,United States
Clinical Trial Site
Recruiting
Fresno,California,93720,United States
Clinical Trial Site
Recruiting
Philadelphia,Pennsylvania,19144,United States
Clinical Trial Site
Recruiting
New Orleans,Louisiana,70112,United States
Clinical Trial Site
Recruiting
Madison,Wisconsin,53705,United States
Clinical Trial Site
Recruiting
La Jolla,California,92037,United States
Clinical Trial Site
Recruiting
Pittsburgh,Pennsylvania,15232,United States
Clinical Trial Site
Recruiting
Baltimore,Maryland,21204,United States
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.