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ANV600

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Apr 14, 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 Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06470763A Study Evaluating ANV600 Single Agent or in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (EXPAND-1)PHASE1 ACTIVE NOT_RECRUITING 240Jul 1, 2024Feb 1, 2028Apr 14, 202618 United States, Belgium +5
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Study Endpoints
Primary Endpoints
Phase I dose escalation: Incidence of Dose Limiting Toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab combination with pembrolizumab
Day 1 up to 24 months
Phase I dose escalation: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab
Day 1 up to 24 months
Phase II: Objective Response Rate (ORR) using RECIST v1.1
Day 1 up to 24 months
Phase II: Duration of Response (DOR) using RECIST v1.1
Day 1 up to 24 months
Secondary Endpoints
Phase I Dose escalation: Serum concentration of ANV600 following a single dose and after repeated dosing
Day 1 up to 24 months
Phase I Dose escalation: Immunogenicity as indicated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (nAb)
Day 1 up to 24 months
Phase I Dose escalation: Objective response rate (ORR) using RECIST v1.1
Day 1 up to 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ANV600 single agentEXPERIMENTAL -
ANV600 in combination with pembrolizumab (KEYTRUDA®)EXPERIMENTAL -
Interventions
NameTypeDescription
ANV600DRUGANV600 administered by intravenous (IV) infusion
ANV600 + pembrolizumab (KEYTRUDA®)DRUGANV600 administered by intravenous (IV) infusion pembrolizumab (KEYTRUDA®) administered by intravenous (IV) infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * The participant provides written informed consent for the trial; * Life-expectancy ≥ 3 months; * Able to comply with the Protocol as judged by the Investigator; * ≥ 18 years of age on day of signing informed consent; * Eastern Cooperative Oncology Group (ECOG) performance stat...

Countries:United StatesBelgiumFranceGermanyNetherlandsSpainSwitzerland
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06470763studyFirstPostDate: changed