Prostate Cancer MetastaticPhase 1NCT05177042
Trial of ARV-110 and Abiraterone in Participants With Metastatic Prostate Cancer
A Phase 1 study testing Bavdegalutamide and Abiraterone in people with Prostate Cancer Metastatic, run by Arvinas Androgen Receptor, Inc. at 18 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- Bavdegalutamide and Abiraterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 13 May 2022to 10 Apr 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
- Any of the following in the previous 6 months: congenital long QT syndrome, Torsade de Pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), left anterior hemiblock (bifascicular block), or ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ≥2, atrial fibrillation of any grade (Grade ≥2 in the case of asymptomatic lone atrial fibrillation).
- Hypertension that cannot be controlled by medications (>150/90 millimeters of mercury [mmHg] despite optimal medical therapy).
- Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.
- Active inflammatory gastrointestinal disease, uncontrolled chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery. Gastroesophageal reflux disease is allowed except for if under treatment with proton pump inhibitors.
- Participants with Child Pugh C.
- Participants with electrolyte imbalances of hypokalemia, hypomagnesemia, and/or hypocalcemia.
- Participants with QTcF ≥470 millisecond (msec).
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
United States9 sites
Clinical Trial Site
Boston, Massachusetts, 02114
Clinical Trial Site
Charlottesville, Virginia, 22903
Clinical Trial Site
Columbus, Ohio, 43210
Clinical Trial Site
Fort Myers, Florida, 33916
Clinical Trial Site
Myrtle Beach, South Carolina, 29572
Clinical Trial Site
Nashville, Tennessee, 37203
Clinical Trial Site
New Haven, Connecticut, 06519
Clinical Trial Site
Portland, Oregon, 97239
Clinical Trial Site
Santa Monica, California, 91361
Canada3 sites
Clinical Trial Site
Montreal, Quebec
Clinical Trial Site
Toronto, Ontario
Clinical Trial Site
Vancouver, British Columbia
France3 sites
Clinical Trial Site
Caen
Clinical Trial Site
Paris
Clinical Trial Site
Villejuif
United Kingdom3 sites
Clinical Trial Site
Cardiff, Wales
Clinical Trial Site
London, England
Clinical Trial Site
Preston, PR2 9HT
About this study
Official title: A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
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.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- Bavdegalutamide, Abiraterone
- Keywords
- Metastatic Prostate Cancer, Prostate Cancer, Castrate-Resistant, mCRPC, bavdegalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BavdegalutamideDrug
Also called ARV-110
Bavdegalutamide oral tablets daily in 28 day cycles.
AbirateroneDrug
Abiraterone oral tablets daily at the same dose they were on prior to study enrollment with a concomitant corticosteroid of Investigator's choice as per local label/guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Bavdegalutamide + Abiraterone (Safety Lead-in) | Experimental | Male participants received 420 milligrams (mg) bavdegalutamide (3*140 mg tablets) orally once daily with food and continued taking abiraterone orally once daily at the same dose they were taking before enrolling in the study, on an empty stomach (at least 1 hour before or 2 hours after a meal), along with a corticosteroid of the investigator's choice, per the local guidelines or product label in initial safety lead-in phase until disease progression, an adverse event (AE) leading to discontinuation of the study treatment, death, withdrawal of consent, or any criteria were met for discontinuation. Receives: Drug: Bavdegalutamide; Drug: Abiraterone |
| Bavdegalutamide + Abiraterone (Expansion Phase) | Experimental | After the Recommended Phase 2 Dose (RP2D) was determined, additional male participants were enrolled and participants from safety lead-in phase continued to receive 420 mg bavdegalutamide (3*140 mg tablets) orally once daily with food and continued taking abiraterone orally once daily at the same dose they were taking before enrolling in the study, on an empty stomach (at least 1 hour before or 2 hours after a meal), along with a corticosteroid of the investigator's choice, per the local guidelines or product label until disease progression, an AE leading to discontinuation of the study treatment, death, withdrawal of consent, or any criteria were met for discontinuation. Receives: Drug: Bavdegalutamide; Drug: Abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Lead-in: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
DLT was defined as: Grade >=3 hematologic parameters, Grade ≥ 3 neutropenia with infection, Grade 4 neutropenia lasting > 5 days, Febrile neutropenia, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 4 thrombocytopenia, any toxicity requiring dose interruption for >=14 days; Grade >=3 non-hematologic toxicities considered clinically significant and non-clinically significant Grade >=3 toxicities requiring dose interruption for >=10 days that determined by the investigator to be clinically relevant. Severity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Baseline (Day 1) up to Day 28
Safety Lead-in: Recommended Phase 2 Dose (RP2D) of Bavdegalutamide
Dose limiting toxicities in first 4 weeks of the study combination treatment assessed to determine the dose of bavdegalutamide associated with acceptable safety and tolerability.
Measured: Baseline (Day 1) up to Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. A TEAE is an AE occurring on/after the date of first dose of bavdegalutamide and on-study abiraterone and within 30 days of the last dose of bavdegalutamide and on-study abiraterone. TEAEs included both Serious TEAEs and non-serious TEAEs.
Measured: 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)
Secondary outcomes (16)
Safety Lead-in: Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of Bavdegalutamide and Abiraterone
AUCtau is defined as area under the concentration-time curve during a dosing interval.
Measured: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Area Under the Concentration-time Curve From Time 0 Through the Last Measurable Concentration (AUClast) of Bavdegalutamide and Abiraterone
AUClast is defined as area under the concentration-time curve from time 0 through the last measurable concentration (AUClast).
Measured: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Maximum Observed Plasma Concentration (Cmax) of Bavdegalutamide and Abiraterone
Cmax is the maximum observed plasma concentration.
Measured: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Minimum Observed Plasma Concentration (Cmin) of Bavdegalutamide and Abiraterone
Cmin is the minimum observed plasma concentration.
Measured: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Time of Maximum Observed Plasma Concentration (Tmax) of Bavdegalutamide and Abiraterone
Tmax is the time of maximum observed plasma concentration.
Measured: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Last Measurable Plasma Concentration (Clast) of Bavdegalutamide and Abiraterone
Clast is the last measurable plasma concentration.
Measured: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Time of Last Measurable Plasma Concentration (Tlast) of Bavdegalutamide and Abiraterone
Tlast is the time of last measurable plasma concentration.
Measured: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Percentage of Participants With Lack of Prostate-Specific Antigen (PSA) Progression
PSA control rate was defined as the percentage of participants with lack of PSA progression at 12 weeks. PSA progression was defined as a >=25% increase in PSA and an absolute increase in PSA of >=2 nanograms per milliliter (ng/mL) above the nadir, which was confirmed by a second consecutive value obtained 3 or more weeks later.
Measured: Baseline (Day 1) up to 12 weeks
PSA30 Response Rate
A PSA30 response rate was the percentage of participants with a PSA30 response. A PSA30 response was defined as a >=30% decline in PSA from baseline. This decline must have been confirmed to be sustained by a second PSA performed >=3 weeks later. Baseline was defined as the last available observation prior to or on the first administration of bavdegalutamide and on study abiraterone.
Measured: Baseline up to approximately 152 weeks
PSA50 Response Rate
A PSA50 response rate was the percentage of participants with a PSA50 response. A PSA50 response was defined as a >=50% decline in PSA from baseline. This decline must have been confirmed to be sustained by a second PSA performed >=3 weeks later. Baseline was defined as the last available observation prior to or on the first administration of bavdegalutamide and on study abiraterone.
Measured: Baseline up to approximately 152 weeks
Duration of PSA30 Response
Duration of PSA30 response was the time interval from the date of the first confirmed PSA30 response to the date of confirmed PSA progression. Participants who did not have PSA progression were to be censored on the date of the last PSA assessment before receipt of new subsequent anticancer therapy. A PSA30 response was defined as a >=30% decline in PSA from baseline. This decline must have been confirmed to be sustained by a second PSA performed >=3 weeks later. PSA progression was defined as a >=25% increase in PSA and an absolute increase in PSA of >=2 ng/mL above the nadir, which was confirmed by a second consecutive value obtained 3 or more weeks later. Baseline was defined as the last available observation prior to or on the first administration of bavdegalutamide and on study abiraterone. Kaplan-Meier estimates were used for analysis.
Measured: From the date of the first confirmed PSA30 response up to confirmed PSA progression (assessed up to approximately 152 weeks)
Duration of PSA50 Response
Duration of PSA50 response was the time interval from the date of the first confirmed PSA50 response to the date of confirmed PSA progression. Participants who did not have PSA progression were to be censored on the date of the last PSA assessment before receipt of new subsequent anticancer therapy. A PSA50 response was defined as a >=50% decline in PSA from baseline. This decline must have been confirmed to be sustained by a second PSA performed >=3 weeks later. PSA progression was defined as a >=25% increase in PSA and an absolute increase in PSA of >=2 ng/mL above the nadir, which was confirmed by a second consecutive value obtained 3 or more weeks later. Baseline was defined as the last available observation prior to or on the first administration of bavdegalutamide and on study abiraterone. Kaplan-Meier estimates were used for analysis.
Measured: From the date of the first confirmed PSA50 response up to confirmed PSA progression (assessed up to approximately 152 weeks)
Time to PSA Progression
Time to PSA progression was the time interval from the date of the first study dose to the date of PSA progression. The PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 ng/mL above the nadir was documented, which was confirmed by a second consecutive value obtained >=3 weeks later. Participants who did not have PSA progression were to be censored on the date of the last PSA assessment before receipt of new anticancer therapy. If a participant did not have a postbaseline PSA, they were to be censored on the date of the first study dose. Kaplan-Meier estimates were used for analysis.
Measured: From first dose up to date of PSA progression (assessed up to approximately 152 weeks)
Radiographic Progression-Free Survival (rPFS)
rPFS was defined as the time interval from the date of the first study dose to the date of first progression per modified Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1)/Prostate Cancer Working Group 3 (PCWG3) Criteria, or death from any cause, whichever occurred first. Radiological progression was defined by either soft tissue tumor progression defined by RECIST v1.1, or bone progression defined by PCWG2. Bone progression was defined as a minimum of two new lesions. Progression on bone scans before or at week 8 required a confirmatory scan performed 6 or more weeks later. rPFS was analyzed using Kaplan-Meier methodology. Participants who were alive and whose disease did not progress were to be censored on the date of the last disease assessment before receipt of new anticancer therapy. If the participant was alive and did not have post baseline imaging assessment, participant was to be censored on the date of the first study drug dose.
Measured: From first dose to the date of first progression (assessed up to approximately 152 weeks)
Overall Response Rate (ORR) by Modified RECIST v1.1)/PCWG3 Criteria
ORR was defined as the percentage of participants whose best overall response was a confirmed complete response (CR) or confirmed partial response (PR), as determined by the investigator according to modified RECIST v1.1/PCWG3. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.
Measured: From first dose up to approximately 152 weeks
Duration of Radiographic Response (DOR)
DOR was defined as the time interval from the date of first documented confirmed CR/PR to the date of the first documented tumor progression (per modified RECIST 1.1/PCWG3 criteria), or death, whichever occurred first. CR was defined as complete disappearance of all target lesions and non-target disease and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. Radiological progression was defined by either soft tissue tumor progression defined by RECIST v1.1, or bone progression defined by PCWG2. Bone progression was defined as a minimum of two new lesions. Progression on bone scans before or at week 8 required a confirmatory scan performed 6 or more weeks later.
Measured: From the date of first documented confirmed response to the date of the first documented tumor progression (assessed up to approximately 152 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start13 May 2022
- Primary completion2 Jul 2024
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arvinas Androgen Receptor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177042
- Sponsor's protocol ID
- ARV-110-mCRPC-103
- Other IDs
- 2021-003046-21, 2024-516661-37-00
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2021
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT05177042
- Acronym / sponsor ID
- ARV-110-mCRPC-103
- Conditions
- Prostate Cancer Metastatic
- Keywords
- Metastatic Prostate Cancer, Prostate Cancer, Castrate-Resistant, mCRPC, bavdegalutamide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Arvinas Androgen Receptor, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bavdegalutamide + Abiraterone (Safety Lead-in) | Experimental | Drug: Bavdegalutamide, Drug: AbirateroneMale participants received 420 milligrams (mg) bavdegalutamide (3*140 mg tablets) orally once daily with food and continued taking abiraterone orally once daily at the same dose they were taking before enrolling in the study, on an empty stomach (at least 1 hour before or 2 hours after a meal), along with a corticosteroid of the investigator's choice, per the local guidelines or product label in initial safety lead-in phase until disease progression, an adverse event (AE) leading to discontinuation of the study treatment, death, withdrawal of consent, or any criteria were met for discontinuation. |
| Bavdegalutamide + Abiraterone (Expansion Phase) | Experimental | Drug: Bavdegalutamide, Drug: AbirateroneAfter the Recommended Phase 2 Dose (RP2D) was determined, additional male participants were enrolled and participants from safety lead-in phase continued to receive 420 mg bavdegalutamide (3*140 mg tablets) orally once daily with food and continued taking abiraterone orally once daily at the same dose they were taking before enrolling in the study, on an empty stomach (at least 1 hour before or 2 hours after a meal), along with a corticosteroid of the investigator's choice, per the local guidelines or product label until disease progression, an AE leading to discontinuation of the study treatment, death, withdrawal of consent, or any criteria were met for discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BavdegalutamideAlso: ARV-110Bavdegalutamide oral tablets daily in 28 day cycles. | Drug | Bavdegalutamide + Abiraterone (Expansion Phase), Bavdegalutamide + Abiraterone (Safety Lead-in) |
| AbirateroneAbiraterone oral tablets daily at the same dose they were on prior to study enrollment with a concomitant corticosteroid of Investigator's choice as per local label/guidelines. | Drug | Bavdegalutamide + Abiraterone (Expansion Phase), Bavdegalutamide + Abiraterone (Safety Lead-in) |
Primary outcome
Safety Lead-in: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Time frame: Baseline (Day 1) up to Day 28
DLT was defined as: Grade >=3 hematologic parameters, Grade ≥ 3 neutropenia with infection, Grade 4 neutropenia lasting > 5 days, Febrile neutropenia, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 4 thrombocytopenia, any toxicity requiring dose interruption for >=14 days; Grade >=3 non-hematologic toxicities considered clinically significant and non-clinically significant Grade >=3 toxicities requiring dose interruption for >=10 days that determined by the investigator to be clinically relevant. Severity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Safety Lead-in: Recommended Phase 2 Dose (RP2D) of Bavdegalutamide
Time frame: Baseline (Day 1) up to Day 28
Dose limiting toxicities in first 4 weeks of the study combination treatment assessed to determine the dose of bavdegalutamide associated with acceptable safety and tolerability.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs
Time frame: 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)
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. A TEAE is an AE occurring on/after the date of first dose of bavdegalutamide and on-study abiraterone and within 30 days of the last dose of bavdegalutamide and on-study abiraterone. TEAEs included both Serious TEAEs and non-serious TEAEs.
16 secondary outcomes
Safety Lead-in: Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of Bavdegalutamide and Abiraterone
Time frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Area Under the Concentration-time Curve From Time 0 Through the Last Measurable Concentration (AUClast) of Bavdegalutamide and Abiraterone
Time frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Maximum Observed Plasma Concentration (Cmax) of Bavdegalutamide and Abiraterone
Time frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Minimum Observed Plasma Concentration (Cmin) of Bavdegalutamide and Abiraterone
Time frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Time of Maximum Observed Plasma Concentration (Tmax) of Bavdegalutamide and Abiraterone
Time frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Last Measurable Plasma Concentration (Clast) of Bavdegalutamide and Abiraterone
Time frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Safety Lead-in: Time of Last Measurable Plasma Concentration (Tlast) of Bavdegalutamide and Abiraterone
Time frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
Percentage of Participants With Lack of Prostate-Specific Antigen (PSA) Progression
Time frame: Baseline (Day 1) up to 12 weeks
PSA30 Response Rate
Time frame: Baseline up to approximately 152 weeks
PSA50 Response Rate
Time frame: Baseline up to approximately 152 weeks
Duration of PSA30 Response
Time frame: From the date of the first confirmed PSA30 response up to confirmed PSA progression (assessed up to approximately 152 weeks)
Duration of PSA50 Response
Time frame: From the date of the first confirmed PSA50 response up to confirmed PSA progression (assessed up to approximately 152 weeks)
Time to PSA Progression
Time frame: From first dose up to date of PSA progression (assessed up to approximately 152 weeks)
Radiographic Progression-Free Survival (rPFS)
Time frame: From first dose to the date of first progression (assessed up to approximately 152 weeks)
Overall Response Rate (ORR) by Modified RECIST v1.1)/PCWG3 Criteria
Time frame: From first dose up to approximately 152 weeks
Duration of Radiographic Response (DOR)
Time frame: From the date of first documented confirmed response to the date of the first documented tumor progression (assessed up to approximately 152 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer Metastatic
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bavdegalutamide and Abiraterone in people with Prostate Cancer Metastatic, run by Arvinas Androgen Receptor, Inc. at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Lead-in: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) (time frame: Baseline (Day 1) up to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.