Active — Not RecruitingPhase 1/2

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

United States152 participantsStarted 2021-09-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Incidence of Dose Limiting Toxicities of ARV-766

Timeframe: 28 Days

Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766

Timeframe: 28 Days

Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766

Timeframe: 28 Days

Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC

Timeframe: 12 Weeks

Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination

Timeframe: 28 Days

Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination

Timeframe: 28 Days

Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination

Trial details

NCT IDNCT05067140

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-25

View on ClinicalTrials.gov More Prostate Cancer Metastatic trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A: Incidence of Dose Limiting Toxicities of ARV-766

Timeframe: 28 Days

Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766

Timeframe: 28 Days

Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766

Timeframe: 28 Days

Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC

Timeframe: 12 Weeks

Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination

Timeframe: 28 Days

Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination

Timeframe: 28 Days

Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination