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

Arvinas

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Prostate Cancer Metastatic

Treatments: Drug: ARV-766 + Abiraterone Part C&D; Drug: ARV-766 Part A&B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05067140

ARV-766-mCRPC-101

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

ARV-766

Experimental group

Description:

Oral tablets, once daily in 28 day cycles

Treatment:

Drug: ARV-766 Part A&B

ARV-766 + Abiraterone

Experimental group

Description:

Oral tablets, once daily in 28 day cycles

Treatment:

Drug: ARV-766 + Abiraterone Part C&D