Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Immune System Diseases

Prostatic Neoplasms

Adenocarcinoma

Hypersensitivity

Urogenital Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Oral tablets, once daily in 28 day cycles

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 Part A&B

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

ARV-766 + Abiraterone Part C&D

Arvinas Androgen Receptor, Inc.

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.

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

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

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

Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.

Evaluate PSA in patients with mCRPC in both dose groups

Evaluate PSA in patients with NHA-naïve mPC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer	NCT05067140	Prostate Cancer...	ARV-766 Part A&... ARV-766 + Abira...	18 Years -	Arvinas Inc.
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer	NCT05067140	Prostate Cancer...	ARV-766 Part A&... ARV-766 + Abira...	18 Years -	Arvinas Inc.

Spots Global Cancer Trial Database for mcrpc adenocarcinoma of prostate