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GDC-1261

Phase 1

Advanced Prostate Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Sep 4, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment260

FDA Designations

No designations recorded

Clinical trial landscape

GDC-1261 · 1 trial · 2 indications

Phase 1 1
NCT07567846A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate CancerAdvanced Prostate Cancer
RECRUITING260 Analytics
PHASE1RECRUITING
A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
Advanced Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Adverse Events (AEs)
Up to approximately 24 months
Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs)
From Day 1-28 of Cycle 1 (1 Cycle = 28 days)

Secondary Endpoints

Plasma Concentration of GDC-1261
Up to approximately 24 months
Plasma Concentration of GDC-1261 Either in Fasted or Fed State
Up to approximately 24 months
Prostate-Specific Antigen-30% (PSA30) Response Rate
Up to approximately 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation + ExpansionEXPERIMENTALParticipants will receive GDC-1261 as per the schedule described in the protocol.

Interventions

NameTypeDescription
GDC-1261DRUGParticipants will receive GDC-1261 as per the schedule described in the protocol.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of \<=1 * Life expectancy is \>= 3 months * Histologically or cytologically confirmed prostate adenocarcinoma * Disease progression during or following the direct prior line of therapy * Ongoing androgen deprivation ...

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

Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT07567846lastUpdatePostDate: changed
LOWAug 11, 2026NCT07567846lastUpdatePostDate: changed
LOWAug 11, 2026NCT07567846lastUpdatePostDate: changed
LOWAug 11, 2026NCT07567846lastUpdatePostDate: changed
LOWJul 9, 2026NCT07567846lastUpdatePostDate: changed
LOWJul 9, 2026NCT07567846lastUpdatePostDate: changed

Frequently asked questions about GDC-1261

What is GDC-1261 used for in advanced prostate cancer?

GDC-1261 is an investigational small molecule being studied for the treatment of advanced or metastatic prostate cancer. It is currently in Phase 1 clinical development, with a trial evaluating its safety, pharmacokinetics, and preliminary activity in participants with advanced or metastatic prostate cancer.

Who makes GDC-1261?

GDC-1261 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial of the drug in participants with advanced or metastatic prostate cancer.

What phase is GDC-1261 in?

GDC-1261 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being evaluated in a Phase 1 study for advanced or metastatic prostate cancer.

What clinical trials is GDC-1261 in?

GDC-1261 is being studied in a single Phase 1 clinical trial with the identifier NCT07567846. The trial is recruiting participants with advanced or metastatic prostate cancer and is being conducted in the United States, Australia, and the United Kingdom.

Is GDC-1261 the same as any other drug?

No alternative names for GDC-1261 have been disclosed. The drug is identified solely as GDC-1261 in its clinical trial documentation.