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Pembrolizumab - anti-PD-1 antibody

Phase 1

Solid Tumor, Adult | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Dec 18, 2025

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04130516Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With PembrolizumabPHASE1 RECRUITING 200 — — Oct 21, 2019Dec 15, 2027Dec 18, 202510 United States
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Study Endpoints
Primary Endpoints
Adverse events observed for LNS8801 dosed alone and in combination with pembrolizumab
Duration of study, approximately 24 months
Secondary Endpoints
LNS8801 plasma exposure (AUC) as a function of dose
During first 23 days of dosing
LNS8801 plasma exposure (Cmax) as a function of dose
During the first 23 days of dosing
LNS8801 plasma exposure (t1/2) as a function of dose
During the first 23 days of dosing
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveOTHERPhase 1/2 open-label
Interventions
NameTypeDescription
LNS8801 -Small molecule, orally bioavailable, selective agonist of GPERDRUGLNS8801 -Small molecule, orally bioavailable, selective agonist of GPER
Pembrolizumab - anti-PD-1 antibodyBIOLOGICALpembrolizumab- anti-PD-1 antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Prescreening Inclusion Criteria for genotyping: 1. Has histopathologically confirmed locally advanced or metastatic solid tumor cancer. 2. Is able to understand and voluntarily sign a written informed consent form and is willing and able to comply with protocol requirements. 3. Is considered likely...

Countries:United States
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