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Bapotulimab

Phase 1

Advanced Solid Tumor | Monoclonal antibody | Oncology |Bayer AG|Trials Updated: May 28, 2024

Bapotulimab target and mechanism

Target class-Mab (Antibody)
ModalityMonoclonal antibody

Also known as Bapotulimab (BAY1905254)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Bapotulimab clinical trials

Bapotulimab · 1 trial · 2 indications

Phase 1 1
NCT03666273Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.Advanced Solid Tumor
COMPLETED60 Analytics
PHASE1COMPLETED
Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent AEs (TEAEs) including treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and dose-limiting toxicities (DLTs)
Up to 58 months
Severity of treatment-emergent AEs (TEAEs) including treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and dose-limiting toxicities (DLTs)
Up to 58 months
Cmax of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg
Up to 504 hours after drug in Cycle 1

Maximum plasma concentration after single dose

AUC of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg
Up to 504 hours after drug in Cycle 1

Area under the plasma concentration curve after single dose

Maximum tolerated dose (MTD) of Bapotulimab
Up to 58 months

Secondary Endpoints

Recommended dose of Bapotulimab for Phase 2
Up to 58 months
Cmax,md after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
Up to 504 hours after drug in Cycle 3
AUC after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
Up to 504 hours after drug in Cycle 3
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose escalation_MonotherapyEXPERIMENTALPatients with solid tumor types considered immunosensitive
Dose escalation_Combination therapyEXPERIMENTALPatients with solid tumor types considered immunosensitive
Expansion HNSCC_Combination therapyEXPERIMENTALPatients with head and neck squamous cell carcinoma (HNSCC)

Interventions

NameTypeDescription
Bapotulimab (BAY1905254)DRUGIntravenous administration of escalating doses of Bapotulimab
Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)DRUGIntravenous administration of Bapotulimab of fixed dose (expansion), and of a fixed dose of pembrolizumab
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Main Inclusion Criteria: * Male or female patients aged ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Patients must have measurable disease (at least one unidimensional measurable lesion by Computed tomography \[CT\] or Magnetic resonance imaging \[MRI\]) p...

Countries:United States
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about Bapotulimab

What is Bapotulimab?

Bapotulimab is an investigational monoclonal antibody being developed by Bayer AG for advanced solid tumors. It is a Phase 1 clinical-stage candidate studied in oncology, including head and neck squamous cell carcinoma. Bapotulimab has also been referred to as BAY1905254 in company and trial documentation.

What is Bapotulimab used for?

Bapotulimab is being studied for the treatment of advanced solid tumors, including head and neck squamous cell carcinoma that has returned or is metastatic and expresses PD-L1. It is an investigational agent and has not been approved for any indication.

Who makes Bapotulimab?

Bapotulimab is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating Bapotulimab in advanced solid tumors.

What phase is Bapotulimab in?

Bapotulimab is in Phase 1 clinical development. The single registered trial, NCT03666273, has been completed. Bapotulimab remains an investigational drug and is not FDA approved.

What clinical trials is Bapotulimab in?

Bapotulimab has been evaluated in one clinical trial, NCT03666273, a Phase 1 study in advanced solid tumors and head and neck squamous cell carcinoma conducted in the United States. The trial enrolled 60 participants and is completed.

Is Bapotulimab the same as BAY1905254?

Yes, Bapotulimab is also known as BAY1905254. BAY1905254 is the Bayer compound code used for the same monoclonal antibody, and both names refer to the same investigational oncology drug.