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 Pembolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.

  • End date
    May 30, 2024
  • participants needed
  • sponsor
Updated on 18 September 2021
renal function


This study is being done to learn more about a new drug called Bapotulimab given in combination with Pembrolizumab. The purpose of this study is to learn if this new combination of drugs is safe for the participants, how it affects the body and to try to find the best dose of the new drug to give to participants and to obtain a preliminary assessment of the tumor response efficacy in the recurrent or metastatic Head and Neck Cancer.

Condition Advanced Solid Tumor, Advanced Malignant Solid Tumor, Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma, Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma, Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma, Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma, Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma
Treatment BAY1905254, BAY1905254 + Pembrolizumab, Bapotulimab (BAY1905254), Bapotulimab (BAY1905254) + Pembrolizumab
Clinical Study IdentifierNCT03666273
Last Modified on18 September 2021


Yes No Not Sure

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]) per Response evaluation criteria in solid tumors (RECIST) 1.1, and following histologically confirmed, advanced or metastatic solid tumors
Dose escalation: All solid tumor types with a likelihood of sensitivity to immunotherapy, as judged by the investigator
Expansion of Bapotulimab in combination with pembrolizumab in Head and neck squamous cell carcinoma (HNSCC): recurrent or metastatic head and neck squamous cell carcinoma IO-nave PDL1+/ CPS1(PD-L1: Programmed death ligand 1; CPS: Combined positive score)
Provision of archival tumor tissue at screening is mandatory for all patients in dose escalation
For dose escalation, patients: must have received standard therapy or have no standard therapy available or patients have actively refused any treatment which would be regarded standard. Or in the opinion of investigator have been considered ineligible for a particular form of standard therapy on medical grounds
Adequate bone marrow, liver and renal function
Adequate cardiac function, measured by echocardiography

Exclusion Criteria

History of severe immune related adverse effects from prior immunotherapy (CTCAE v.5.0 Grade 4; CTCAE v.5.0 Grade 3 requiring treatment > 4 weeks), except hypothyroidism clinically stable on hormone replacement treatment and controlled type 1 diabetes
Severe (CTCAE v.5.0 Grade 3) infections within 4 weeks before the first study drug administration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Clinically active infections (CTCAE v.5.0 > Grade 1) within 2 weeks before the first study drug administration
Previous or active myocarditis/myositis in history (independent of cause)
Active or history of autoimmune disease
Known human immunodeficiency virus (HIV) infection
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Treatment with systemic immunosuppressant medications within 2 weeks before the first study drug administration
Ongoing or previous anti-cancer treatment or any immunostimulatory treatment including but not limited to interferons (IFNs), interleukin (IL)-2 and agonists for members of the tumor necrosis factor (TNF) receptor superfamily (e.g. 4-1BB) within 4 weeks before the first study drug administration
For dose expansion cohort of Bapotulimab in combination with pembrolizumab in HNSCC: has progressive disease (PD) within six (6) months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC
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