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.
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
Drug | Synonyms | Arms |
---|
Bapotulimab (BAY1905254) | | Dose escalation_Monotherapy |
Bapotulimab (BAY1905254) + Pembrolizumab | | Dose 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
Name | Type | Description | Interventions |
---|
Dose escalation_Monotherapy | Experimental | Patients with solid tumor types considered immunosensitive | |
Dose escalation_Combination therapy | Experimental | Patients with solid tumor types considered immunosensitive | - Bapotulimab (BAY1905254) + Pembrolizumab
|
Expansion HNSCC_Combination therapy | Experimental | Patients 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