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Bavdegalutamide

Phase 1

Prostate Cancer Metastatic | Small molecule | Oncology |Arvinas, Inc.|Last Updated: Apr 28, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05177042Trial of ARV-110 and Abiraterone in Participants With Metastatic Prostate CancerPHASE1 COMPLETED 45May 13, 2022Apr 10, 2025Apr 28, 202618 United States, Canada +2
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Study Endpoints
Primary Endpoints
Safety Lead-in: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
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
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
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.

Secondary Endpoints
Safety Lead-in: Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of Bavdegalutamide and Abiraterone
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
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
Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Cycle 1 Day 21 (each cycle is of 28 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bavdegalutamide + Abiraterone (Safety Lead-in)EXPERIMENTALMale 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)EXPERIMENTALAfter 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.
Interventions
NameTypeDescription
BavdegalutamideDRUGBavdegalutamide oral tablets daily in 28 day cycles.
AbirateroneDRUGAbiraterone 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: 1. Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate. 2. Ongoing treatment with stable doses of abiraterone (on an empty stomach) and a concomitant corticosteroid for mCRPC or for metastatic castration sensitive prostate cancer (mCS...

Countries:United StatesCanadaFranceUnited Kingdom
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Competitive Landscape -Prostate Cancer 259 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK7PHASE3Pembrolizumab, Enzalutamide, Ifinatamab deruxtecan, Docetaxel, Prednisone
AstraZeneca PLCAZN20PHASE3olaparib, abiraterone, Saruparib, Abiraterone, Darolutamide
Pfizer Inc.PFE12PHASE3Talazoparib with enzalutamide, PF-06821497, Docetaxel, Enzalutamide, Leuprolide Open Label
Johnson & JohnsonJNJ21PHASE3Apalutamide, Androgen Deprivation Therapy, Niraparib, Abiraterone, Prednisone
Eli Lilly and CompanyLLY9PHASE3Abemaciclib, Abiraterone, Prednisone or Prednisolone, -PNT2002, Enzalutamide
Amgen Inc.AMGN7PHASE3Xaluritamig, Abiraterone, Enzalutamide, Cabazitaxel, Docetaxel
Novartis AG Sponsored ADRNVS28PHASE3177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT, AAA617
Exelixis, Inc.EXEL4PHASE3Cabozantinib, Atezolizumab, Abiraterone, Enzalutamide, Prednisone
Candel Therapeutics, Inc.CADL3PHASE3Aglatimagene besadenovec + valacyclovir, aglatimagene besadenovec, valacyclovir, aglatimagene besadenovec + valacyclovir
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone
BioNTech SE Sponsored ADRBNTX1PHASE3BNT324, Docetaxel, Prednisone/prednisolone
Telix Pharmaceuticals Limited Sponsored ADRTLX3PHASE368Ga-PSMA-11, 177Lu-TLX591, Enzalutamide, Abiraterone, Docetaxel
Sanofi SA Sponsored ADRSNY2PHASE3abiraterone, Docetaxel, Cabazitaxel
Regeneron Pharmaceuticals, Inc.REGN4PHASE2REGN2810, Degarelix, Leuprolide, Docetaxel, BPX-601
Veracyte, Inc.VCYT2PHASE2Darolutamide, Zoladex, Zoladex LA, Decapeptyl sustained release, Depo-Eligard
Kyntra Bio, Inc.KYNB2PHASE2FG-3246, FOR46, Enzalutamide, Pegfilgrastim
Lantheus Holdings IncLNTH3PHASE3Undisclosed
IDEAYA Biosciences, Inc.IDYA3PHASE1IDE-161, Pembrolizumab, IDE034, IDE574, Fulvestrant
Xencor, Inc.XNCR1PHASE2vudalimab
GSK plc Sponsored ADRGSK2PHASE1GSK5471713, GSK5458514
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Recent Changes (Last 90 Days)
MEDIUMMay 29, 2026NCT05177042TRIAL_REMOVED: changed
MEDIUMMay 29, 2026NCT05177042TRIAL_REMOVED: changed
MEDIUMMay 29, 2026NCT05177042TRIAL_REMOVED: changed