What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including novel agents like ARV-766, abiraterone, sipuleucel-T, and olaparib, have a range of side effects. Abiraterone can cause hypertension and hypokalemia. Sipuleucel-T is generally well-tolerated but may not significantly improve overall survival or disease progression. Olaparib is associated with anemia, nausea, anorexia, and fatigue, which are mostly low grade and manageable. General side effects of prostate cancer treatments can include neutropenia, gastrointestinal issues, and fatigue.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of prostate cancer, particularly focusing on castration-resistant prostate cancer (CRPC). Androgen receptor inhibitors like enzalutamide and androgen synthesis inhibitors such as abiraterone acetate have been approved and are commonly used. Additionally, combination therapies involving these agents, such as abiraterone with prednisone, have shown significant efficacy. Other notable treatments include the radioligand therapy lutetium Lu 177 vipivotide tetraxetan and the PARP inhibitors rucaparib and niraparib for patients with specific genetic mutations. These treatments aim to manage disease progression and improve overall survival in patients with advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to ARV-766 for prostate cancer patients include ARV-110, a proteolysis-targeting chimera that degrades the androgen receptor, and the combination of abiraterone with olaparib, which has shown improved progression-free survival. Bipolar Androgen Therapy (BAT) is also a potential alternative, particularly for restoring sensitivity to other treatments.

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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

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral drug called ARV-766, alone or with abiraterone, in men with advanced prostate cancer that has spread. The drug works by blocking proteins that help cancer cells grow. Abiraterone is a well-established drug used in the treatment of metastatic castration-resistant prostate cancer, often in combination with other therapies.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met

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.