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GDC-7035

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as Phase I Arm A, Phase I Arm B

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

GDC-7035 · 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 Tumor
NCT06619587410
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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")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)

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