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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 Tumor Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Advanced Solid Tumor
  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT03666273
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 1
Start date September 12, 2018
Completion date May 15, 2024
View Details
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