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ARV-806

Phase 1

KRAS G12D Mutation | Small molecule | Oncology |Arvinas, Inc.|Last Updated: Feb 19, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment159
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07023731A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D MutationPHASE1 RECRUITING 159 — — May 29, 2025Apr 2, 2029Feb 19, 202614 United States
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Study Endpoints
Primary Endpoints
Part A (Phase 1): Number of dose-limiting toxicities of ARV-806
28 days from first ARV-806 administration

Number of participants within a dose escalation cohort with adverse events (AEs) meeting protocol defined dose limiting toxicities during cycle 1 (28 days).

Part A (Phase 1): Number of participants with AEs
From the study baseline to at least 28 days after last dose of ARV-806

AEs as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\]), timing, seriousness, and relationship to study intervention as a measure of safety and tolerability

Part B (Phase 2): Overall Response Rate (ORR)
Approximately 2 years

ORR is a parameter measuring the anti-tumor activity of ARV-806. ORR is the percentage of participants for whom the study treatment resulted in a complete response or partial response of the disease under study. It is measured using CT/MRI and RECIST 1.1 criteria per investigator assessment.

Secondary Endpoints
Pharmacokinetics (PK) of ARV-806 (Part A): Area under the plasma or blood concentration-time profile during a dosing interval (AUC0-tau)
At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806.
PK of ARV-806 (Part A): Area under the plasma or blood concentration time profile from time zero to the time of the last quantifiable concentration (Clast) (AUC0-last)
At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806
PK of ARV-806 (Part A): Maximum plasma or blood concentration (Cmax)
At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1/Part A (Dose Escalation)EXPERIMENTALParticipants will receive ARV-806 at the assigned doses and regimen (weekly or every 2 weeks).
Phase 2/Part B (Dose Expansion)EXPERIMENTALParticipants will receive ARV-806 at one of up to 2 dose levels/regimens selected from Part A)
Interventions
NameTypeDescription
ARV-806DRUGIntravenous infusion at assigned dose and dosing schedule
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: Part A: * Histological or cytological diagnosis of unresectable or metastatic solid tumor malignancy, AND * Must have evidence of KRAS G12D mutation in tumor tissue or blood (circulating tumor deoxyribonucleic acid \[ctDNA\]), AND * Must have received prior standard-of-care (SO...

Countries:United States
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Competitive Landscape -Genetic Mutations 6 trials
CompanyTickerTrialsLead PhaseDrugs
Tango Therapeutics, Inc.TNGX1PHASE1TNG462, RMC-9805, RMC-6236, mFOLFIRINOX, gemcitabine/nab-paclitaxel
Myriad Genetics, Inc.MYGN1PHASE1Melphalan, BCNU, Vitamin B12B, Vitamin C
Adlai Nortye Ltd. Sponsored ADRANL1PHASE1AN9025
Pasithea Therapeutics Corp.KTTA1PHASE1PAS-004
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07023731primaryCompletionDate: changed
LOWMay 24, 2026NCT07023731studyFirstPostDate: changed