Recent Updates
Recently added Catalysts

Bapotulimab

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Bayer AG|Last Updated: May 28, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

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.
Advanced Solid TumorUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about Bapotulimab

What is Bapotulimab used for?

Bapotulimab is an investigational small molecule being studied for the treatment of advanced solid tumors, including head and neck squamous cell carcinoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes Bapotulimab?

Bapotulimab is being developed by Bayer AG, a pharmaceutical company traded on the stock exchange under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical trials for oncology indications.

What phase is Bapotulimab in?

Bapotulimab is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still being evaluated in clinical trials for safety and efficacy in patients with advanced solid tumors.

What clinical trials is Bapotulimab in?

Bapotulimab has been studied in one clinical trial, identified as NCT03666273. This was a Phase 1 study that evaluated the drug in combination with pembrolizumab in patients with head and neck cancer that had returned or metastasized and expressed PD-L1. The trial has been completed.

Is Bapotulimab the same as BAY1905254?

Yes, Bapotulimab is also known as BAY1905254. In clinical trial NCT03666273, the drug is referred to by this alternative name, and the study title explicitly mentions both names to identify the investigational agent being evaluated.