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 | Completed Phase 1 FDA Drug

• 4 other identifiers: 18789MK-3475-920KEYNOTE-9202018-000990-63
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

HNSCC; Head and Neck Cancer; Immunotherapy; PD1, PDL1, ILDR2; Bapotulimab; Pembrolizumab; Immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (5)

• 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

  Maximum plasma concentration after single dose

  Up to 504 hours after drug in Cycle 1

• AUC of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg

  Area under the plasma concentration curve after single dose

  Up to 504 hours after drug in Cycle 1

• Maximum tolerated dose (MTD) of Bapotulimab

  Up to 58 months

Secondary Outcomes (5)

• 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

• Incidence of positive anti-drug antibody titer for Bapotulimab

  Up to 58 months

• Best overall response rate

  Up to 58 months

Study Arms (3)

Dose escalation_Monotherapy

EXPERIMENTAL

Patients with solid tumor types considered immunosensitive

Drug: Bapotulimab (BAY1905254)

Dose escalation_Combination therapy

EXPERIMENTAL

Patients with solid tumor types considered immunosensitive

Drug: Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)

Expansion HNSCC_Combination therapy

EXPERIMENTAL

Patients with head and neck squamous cell carcinoma (HNSCC)

Drug: Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)

Interventions

Bapotulimab (BAY1905254) DRUG

Intravenous administration of escalating doses of Bapotulimab

Dose escalation_Monotherapy

Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®) DRUG

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

Dose escalation_Combination therapy; Expansion HNSCC_Combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-naïve PDL1+/ CPS≥1(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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (8)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics | START San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 11, 2018
• Study Start: September 12, 2018
• Primary Completion: June 16, 2023
• Study Completion: May 15, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

US (8)