NCT03666273

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Bapotulimab (BAY1905254)	Intravenous administration of escalating doses of Bapotulimab
DRUG	Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)	Intravenous administration of Bapotulimab of fixed dose (expansion), and of a fixed dose of pembrolizumab

Timeline

• Start date: 2018-09-12
• Primary completion: 2023-06-16
• Completion: 2024-05-15
• First posted: 2018-09-11
• Last updated: 2024-05-28

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study