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Androgen Receptor Antagonist

ARV-766 +/- Abiraterone for Prostate Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Arvinas Androgen Receptor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial will test a new drug, ARV-766, to see if it is safe and effective in treating men with prostate cancer that has spread and is resistant to hormone therapy.

Who is the study for?
Men with metastatic prostate cancer who've had progression after at least two systemic therapies, including a second-generation androgen inhibitor. They must have an ECOG performance status of 0 or 1, be on ADT, and can't have had more than two chemo regimens. Exclusions include recent anti-cancer therapy, certain gastrointestinal conditions, symptomatic brain metastases requiring steroids, recent radiation therapy or investigational drugs.Check my eligibility
What is being tested?
The trial is testing ARV-766 alone (Part A&B) and in combination with abiraterone (Part C&D), taken orally for men with advanced prostate cancer. It's to see how safe they are and how well they work as treatments.See study design
What are the potential side effects?
While the specific side effects of ARV-766 aren't listed here, common side effects for similar prostate cancer medications may include fatigue, nausea, skin rash, hormonal changes like hot flashes or breast tenderness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently on hormone therapy for cancer or have had an orchiectomy.
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My prostate cancer has worsened despite two prior treatments, including a modern hormone therapy.
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I have taken 1-3 types of specific prostate cancer drugs and no more than 2 chemotherapy treatments for my advanced prostate cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate cancer has been confirmed by a lab test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Incidence of Dose Limiting Toxicities of ARV-766
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: ARV-766 + AbirateroneExperimental Treatment1 Intervention
Oral tablets, once daily in 28 day cycles
Group II: ARV-766Experimental Treatment1 Intervention
Oral tablets, once daily in 28 day cycles

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often target the androgen receptor (AR) pathway, which is critical for the growth and survival of prostate cancer cells. Androgen deprivation therapy (ADT) reduces androgen levels, slowing cancer progression. Androgen receptor signaling inhibitors, such as enzalutamide and abiraterone, block the AR or inhibit androgen production, respectively, further disrupting cancer cell growth. Novel agents like ARV-766 are being studied for their potential to degrade the AR protein, offering a new approach to overcoming resistance to existing therapies. These treatments are vital as they provide multiple strategies to control cancer progression, improving patient outcomes.

Find a Location

Who is running the clinical trial?

Arvinas Androgen Receptor, Inc.Lead Sponsor
3 Previous Clinical Trials
296 Total Patients Enrolled

Media Library

Prostate Cancer Clinical Trial 2023: ARV-766 Highlights & Side Effects. Trial Name: NCT05067140 — Phase 1 & 2
~78 spots leftby Dec 2025
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