Trial of ARV-110 and Abiraterone in Participants With Metastatic Prostate Cancer (NCT05177042) | Clinical Trial Compass
CompletedPhase 1
Trial of ARV-110 and Abiraterone in Participants With Metastatic Prostate Cancer
United States, Canada, France45 participantsStarted 2022-05-13
Plain-language summary
Phase 1b study to assess the combination of ARV-110 (bavdegalutamide) and abiraterone in participants with metastatic prostate cancer with rising PSA values on abiraterone.
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
. Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
. Ongoing treatment with stable doses of abiraterone (on an empty stomach) and a concomitant corticosteroid for mCRPC or for metastatic castration sensitive prostate cancer (mCSPC) until Cycle 1, Day 1 (C1D1).
. Recent Prostate-specific antigen (PSA) values must demonstrate:
. Rising PSAs at least 16 weeks after initiation of abiraterone
. At least 2 PSA values that are higher than the PSA nadir on abiraterone, measured at a minimum of 1 week apart . The screening PSA for this study may be used as the 2nd PSA value.
. No known radiographic evidence of disease progression while receiving abiraterone and clinically benefitting at the time of consent. If there is radiographic disease progression during screening, the participant may be considered eligible if, in the judgement of the investigator, the participant is clinically benefitting from abiraterone.
. Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (surgical or medical castration).
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
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
1
Safety Lead-in: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Timeframe: Baseline (Day 1) up to Day 28
2
Safety Lead-in: Recommended Phase 2 Dose (RP2D) of Bavdegalutamide
Timeframe: Baseline (Day 1) up to Day 28
3
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs
Timeframe: From Day 1 of study treatment in Safety lead-in up to 30 days after end of study treatment (assessed up to approximately 111.57 weeks)
. Previously treated with enzalutamide, apalutamide, darolutamide or experimental therapies (e.g., protein degraders or inhibitors) directed at the androgen receptor.
. Treatment with any chemotherapy, investigational agents, immunotherapy, or hormonal therapy other than gonadotropin-releasing hormone (GnRH) agonists within 28 days of the start of treatment on protocol.
. Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow.
. Participants taking agents that are either a) sensitive P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) substrates, or Cytochrome P450 3A4 (CYP3A4) substrates, b) P-gp, BCRP, CYP3A4, or CYP2D6 substrates that have a narrow therapeutic index, c) strong CYP3A4 inhibitors or inducers, or d) any other prohibited and/or restricted medications described in the protocol.
. Major surgery (as judged by the Investigator) within 4 weeks of first dose of study drug.
. Untreated brain metastases or brain metastases requiring steroids
. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
. Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class II, III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant episode of thromboembolic disease.