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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

Target and mechanism

ModalityMonoclonal antibody

Also known as Pembrolizumab - anti-PD-1 antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment200

FDA Designations

PRIORITY_REVIEW

Clinical trial landscape

Pembrolizumab- anti-PD-1 antibody · 1 trial · 1 indication

Phase 1 1
NCT04130516Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With PembrolizumabSolid Tumor, Adult
RECRUITING200 Analytics
PHASE1RECRUITING
Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
Solid Tumor, AdultUnlock trial analytics

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 to 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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Frequently asked questions about Pembrolizumab- anti-PD-1 antibody

What is Pembrolizumab used for in Solid Tumor, Adult?

Pembrolizumab is an investigational anti-PD-1 monoclonal antibody being studied for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, with an active trial evaluating its safety, tolerability, pharmacokinetics, and anti-tumor effects in this patient population.

What does Pembrolizumab target?

Pembrolizumab targets the programmed cell death protein 1 (PD-1) receptor. As an anti-PD-1 antibody, it is designed to modulate the immune system's response to cancer cells, though the specific mechanism of action in solid tumors is being investigated in ongoing clinical trials.

Who makes Pembrolizumab?

Pembrolizumab is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in adult patients with solid tumors.

What phase is Pembrolizumab in?

Pembrolizumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and pharmacokinetic profile in adults with solid tumors.

What clinical trials is Pembrolizumab in?

Pembrolizumab is being studied in one active Phase 1 clinical trial, NCT04130516, titled 'Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801 alone and With Pembrolizumab.' This trial is recruiting 200 adult participants with solid tumors in the United States.

Is Pembrolizumab the same as Pembrolizumab- anti-PD-1 antibody?

Yes, Pembrolizumab is the same as Pembrolizumab- anti-PD-1 antibody. The name 'Pembrolizumab- anti-PD-1 antibody' is an alternative designation for the drug, which is also known simply as Pembrolizumab. Both names refer to the same investigational anti-PD-1 monoclonal antibody.