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Phase I Arm A

Phase 1

Solid Tumor | Small molecule | Oncology |Roche Holding AG|Last Updated: Aug 25, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment410

FDA Designations

No designations recorded

Clinical trial landscape

Phase I Arm A · 1 trial · 1 indication

Phase 1 1
NCT06619587A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid TumorsSolid Tumor
RECRUITING410 Analytics
PHASE1RECRUITING
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale
4 Years
Percentage of Participants with Dose Limiting Toxicity
4 Years

Secondary Endpoints

Plasma Concentrations of GDC-7035 at Specified Timepoints
4 Years
Blood Concentrations of GDC-7035 at Specified Timepoints
4 Years
Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
4 Years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase I Arm AEXPERIMENTALDose escalation and expansion arm
Phase I Arm BEXPERIMENTALDose escalation and expansion arm

Interventions

NameTypeDescription
Phase I Arm ADRUGDose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
Phase I Arm BDRUGDose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation * Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm Exclusion criteria: * Malabsor...

Countries:United StatesAustraliaCanadaFranceIsraelItalySingaporeSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Recent Changes (Last 90 Days)

LOWAug 25, 2026NCT06619587lastUpdatePostDate: changed
LOWAug 25, 2026NCT06619587lastUpdatePostDate: changed
LOWJul 28, 2026NCT06619587lastUpdatePostDate: changed
LOWJul 28, 2026NCT06619587lastUpdatePostDate: changed

Frequently asked questions about Phase I Arm A

What is Phase I Arm A used for?

Phase I Arm A is an investigational small molecule being studied for the treatment of solid tumors. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities and is still being evaluated for safety and efficacy in patients.

Who makes Phase I Arm A?

Phase I Arm A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety, pharmacokinetics, and activity in patients with advanced solid tumors.

What phase is Phase I Arm A in?

Phase I Arm A is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing trial is recruiting participants to assess the drug's safety, pharmacokinetics, and preliminary activity.

What clinical trials is Phase I Arm A in?

Phase I Arm A is being studied in a single Phase 1 clinical trial with the identifier NCT06619587. This trial is recruiting 410 patients with solid tumors across multiple countries, including the United States, Australia, Canada, France, Israel, Italy, Singapore, South Korea, Spain, and the United Kingdom.

Is Phase I Arm A the same as GDC-7035?

Phase I Arm A is an arm of a clinical trial evaluating the investigational drug GDC-7035. The trial, NCT06619587, studies GDC-7035 as a single agent and in combination in patients with advanced solid tumors. Phase I Arm A refers to a specific treatment group within this trial.