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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
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.
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
Clinical Trial Site
Duarte, California, United States
Part A: Incidence of Dose Limiting Toxicities of ARV-766
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
Time frame: 28 Days
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
Time frame: 28 Days
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
Time frame: 28 Days
Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC
Evaluate PSA in patients with mCRPC in both dose groups
Time frame: 12 Weeks
Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination
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
Time frame: 28 Days
Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
Time frame: 28 Days
Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 13 more locations
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
Time frame: 28 Days
Part D: To evaluate the clinical anti-tumor activity of ARV-766 / abiraterone combination in patients with NHA-naïve mPC
Evaluate PSA in patients with NHA-naïve mPC
Time frame: 12 Weeks