Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Immune Checkpoint Inhibitors

Pembrolizumab

Immunomodulating Agents

Immunoglobulins

Antibodies, Blocking

Antineoplastic Agents, Immunological

Patients with solid tumor types considered immunosensitive

Patients with head and neck squamous cell carcinoma (HNSCC)

Intravenous administration of escalating doses of Bapotulimab

Bapotulimab (BAY1905254)

Intravenous administration of Bapotulimab of fixed dose (expansion), and of a fixed dose of pembrolizumab

Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)

Bayer Study Director

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.

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.

An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of the ILDR2 Function-blocking Antibody BAY1905254 in Patients With Advanced Solid Tumors

Maximum plasma concentration after single dose

Area under the plasma concentration curve after single dose

Maximum plasma concentration after multiple doses

Area under the plasma concentration curve after multiple doses

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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.	NCT03666273	Advanced Solid ... Head and Neck S...	Bapotulimab (BA... Bapotulimab (BA...	18 Years -	Bayer
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.	NCT03666273	Advanced Solid ... Head and Neck S...	Bapotulimab (BA... Bapotulimab (BA...	18 Years -	Bayer

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