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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.

NCT03666273

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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.
  • 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 IDs

  • ORG STUDY ID: 18789
  • SECONDARY ID: MK-3475-920
  • SECONDARY ID: 2018-000990-63
  • NCT ID: NCT03666273

Conditions

  • Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
Bapotulimab (BAY1905254)Dose escalation_Monotherapy
Bapotulimab (BAY1905254) + PembrolizumabDose escalation_Combination therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose escalation_MonotherapyExperimentalPatients with solid tumor types considered immunosensitive
  • Bapotulimab (BAY1905254)
Dose escalation_Combination therapyExperimentalPatients with solid tumor types considered immunosensitive
  • Bapotulimab (BAY1905254) + Pembrolizumab
Expansion HNSCC_Combination therapyExperimentalPatients with head and neck squamous cell carcinoma (HNSCC)
  • Bapotulimab (BAY1905254) + Pembrolizumab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Maximum plasma concentration after single dose

Secondary Outcome Measures

Measure:Recommended dose of Bapotulimab for Phase 2
Time Frame:Up to 58 months
Safety Issue:
Description:
Measure:Cmax,md after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
Time Frame:Up to 504 hours after drug in Cycle 3
Safety Issue:
Description:Maximum plasma concentration after multiple doses
Measure:AUC after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
Time Frame:Up to 504 hours after drug in Cycle 3
Safety Issue:
Description:Area under the plasma concentration curve after multiple doses
Measure:Incidence of positive anti-drug antibody titer for Bapotulimab
Time Frame:Up to 58 months
Safety Issue:
Description:
Measure:Best overall response rate
Time Frame:Up to 58 months
Safety Issue:
Description:Determined by RECIST 1.1

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bayer

Trial Keywords

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

Last Updated

August 6, 2021