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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03666273
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : May 11, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma Drug: Bapotulimab (BAY1905254) Drug: Bapotulimab (BAY1905254) + Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose escalation_Monotherapy
Patients with solid tumor types considered immunosensitive
Drug: Bapotulimab (BAY1905254)
Intravenous administration of escalating doses of Bapotulimab

Experimental: Dose escalation_Combination therapy
Patients with solid tumor types considered immunosensitive
Drug: Bapotulimab (BAY1905254) + Pembrolizumab
Intravenous administration of Bapotulimab of fixed dose (expansion), and of a fixed dose of pembrolizumab

Experimental: Expansion HNSCC_Combination therapy
Patients with head and neck squamous cell carcinoma (HNSCC)
Drug: Bapotulimab (BAY1905254) + Pembrolizumab
Intravenous administration of Bapotulimab of fixed dose (expansion), and of a fixed dose of pembrolizumab




Primary Outcome Measures :
  1. Incidence of treatment-emergent AEs (TEAEs) including treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and dose-limiting toxicities (DLTs) [ Time Frame: Up to 58 months ]
  2. Severity of treatment-emergent AEs (TEAEs) including treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and dose-limiting toxicities (DLTs) [ Time Frame: Up to 58 months ]
  3. Cmax of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg [ Time Frame: Up to 504 hours after drug in Cycle 1 ]
    Maximum plasma concentration after single dose

  4. AUC of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg [ Time Frame: Up to 504 hours after drug in Cycle 1 ]
    Area under the plasma concentration curve after single dose

  5. Maximum tolerated dose (MTD) of Bapotulimab [ Time Frame: Up to 58 months ]

Secondary Outcome Measures :
  1. Recommended dose of Bapotulimab for Phase 2 [ Time Frame: Up to 58 months ]
  2. Cmax,md after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg [ Time Frame: Up to 504 hours after drug in Cycle 3 ]
    Maximum plasma concentration after multiple doses

  3. AUC after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg [ Time Frame: Up to 504 hours after drug in Cycle 3 ]
    Area under the plasma concentration curve after multiple doses

  4. Incidence of positive anti-drug antibody titer for Bapotulimab [ Time Frame: Up to 58 months ]
  5. Best overall response rate [ Time Frame: Up to 58 months ]
    Determined by RECIST 1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main 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-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.

Main 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666273


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-8422937 clinical-trials-contact@bayer.com

Locations
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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
United States, California
University of Southern California Withdrawn
Los Angeles, California, United States, 90033
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
United States, Illinois
University of Chicago Hospitals Recruiting
Chicago, Illinois, United States, 60637
United States, Kentucky
Norton Healthcare Withdrawn
Louisville, Kentucky, United States, 40202
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
United States, New Hampshire
Dartmouth Hitchock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-1000
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
Texas Oncology, PA Withdrawn
Dallas, Texas, United States, 75246
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Millennium Physicians Not yet recruiting
Houston, Texas, United States, 77090
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Belgium
UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Sponsors and Collaborators
Bayer
Merck Sharp & Dohme LLC
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03666273    
Other Study ID Numbers: 18789
MK-3475-920 ( Other Identifier: Merck )
2018-000990-63 ( EudraCT Number )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
HNSCC
Head and Neck Cancer
Immunotherapy
PD1, PDL1, ILDR2
Bapotulimab
Pembrolizumab
Immune checkpoint inhibitor
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents