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RO7656594

Phase 1

Advanced Prostate Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Aug 10, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment210

FDA Designations

No designations recorded

Clinical trial landscape

RO7656594 · 1 trial · 2 indications

Phase 1 1
NCT05800665A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate CancerAdvanced Prostate Cancer
RECRUITING210 Analytics
PHASE1RECRUITING
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Advanced Prostate Cancer
NCT05800665210
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Study Endpoints

Primary Endpoints

Percentage of Participants with Adverse Events
From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Days 1-28 of Cycle 1

Secondary Endpoints

Plasma Concentration of RO7656594
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594
From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594
From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Stage 1: Dose EscalationEXPERIMENTALParticipants will receive RO7656594 administered at a specified dose on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached.
Stage 2: ExpansionEXPERIMENTALParticipants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Interventions

NameTypeDescription
RO7656594DRUGRO7656594 will be administered orally at specified dose on specified days.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites26

Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 2. Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features. 3. Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutami...

Countries:United StatesAustraliaCanadaFranceSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Prostate Cancer 254 trials (matched to "Advanced Prostate Cancer")

Top 20 of 53 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN19PHASE3olaparib, abiraterone
Merck & Co., Inc.MRK6PHASE3Ifinatamab deruxtecan, Docetaxel, Prednisone
Pfizer Inc.PFE12PHASE3Talazoparib with enzalutamide
Johnson & JohnsonJNJ20PHASE3Apalutamide, Androgen Deprivation Therapy
Eli Lilly and CompanyLLY9PHASE3Abemaciclib, Abiraterone, Prednisone or Prednisolone
Amgen Inc.AMGN7PHASE3Xaluritamig, Abiraterone, Enzalutamide, Cabazitaxel
Novartis AG Sponsored ADRNVS27PHASE3177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT
Candel Therapeutics, Inc.CADL3PHASE3Aglatimagene besadenovec, valacyclovir
Exelixis, Inc.EXEL4PHASE3Cabozantinib, Atezolizumab, Abiraterone, Enzalutamide, Prednisone
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone
BioNTech SE Sponsored ADRBNTX1PHASE3BNT324, Docetaxel, Prednisone/prednisolone
Telix Pharmaceuticals Limited Sponsored ADRTLX2PHASE368Ga-PSMA-11
Sanofi SA Sponsored ADRSNY2PHASE3abiraterone, Docetaxel
Regeneron Pharmaceuticals, Inc.REGN4PHASE2REGN2810, Degarelix, Leuprolide, Docetaxel
Veracyte, Inc.VCYT2PHASE2Darolutamide, Zoladex, Zoladex LA, Decapeptyl sustained release, Depo-Eligard
Lantheus Holdings IncLNTH3PHASE3Undisclosed
Xencor, Inc.XNCR1PHASE2vudalimab
Kyntra Bio, Inc.KYNB2PHASE2FG-3246
IDEAYA Biosciences, Inc.IDYA3PHASE1IDE-161, Pembrolizumab
Arcus Biosciences, Inc.RCUS2PHASE2Atezolizumab, Tocilizumab, Etrumadenant
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Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT05800665lastUpdatePostDate: changed
LOWAug 11, 2026NCT05800665lastUpdatePostDate: changed
LOWAug 11, 2026NCT05800665lastUpdatePostDate: changed
LOWJul 10, 2026NCT05800665lastUpdatePostDate: changed
LOWJul 10, 2026NCT05800665lastUpdatePostDate: changed

Frequently asked questions about RO7656594

What is RO7656594 used for?

RO7656594 is an investigational small molecule being developed for the treatment of advanced or metastatic prostate cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes RO7656594?

RO7656594 is being developed by Roche Holding AG, a biopharmaceutical company traded on the OTC market under the ticker RHHBY. The drug is currently in Phase 1 clinical trials.

What phase is RO7656594 in?

RO7656594 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 study is currently recruiting participants with advanced or metastatic prostate cancer.

What clinical trials is RO7656594 in?

RO7656594 is being evaluated in a Phase 1 clinical trial with the identifier NCT05800665. This study is assessing the safety, pharmacokinetics, and activity of the drug in participants with advanced or metastatic prostate cancer and is currently recruiting.

Is RO7656594 being studied in a randomized trial?

No, the Phase 1 clinical trial of RO7656594 is not randomized and is not double-blind. It is a controlled study with an estimated enrollment of 210 male participants aged 18 years and older.