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Advanced Solid TumorPhase 1NCT03666273

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.

A Phase 1 study testing Bapotulimab (BAY1905254) and Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®) in people with Advanced Solid Tumor and Head and Neck Squamous Cell Carcinoma, run by Bayer at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bapotulimab (BAY1905254) and Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
8 sitesUnited States
Study dates
12 Sep 2018to 15 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Chicago Hospitals

    Chicago, Illinois, 60637

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Ohio State University

    Columbus, Ohio, 43210

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • South Texas Accelerated Research Therapeutics | START San Antonio

    San Antonio, Texas, 78229

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

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

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.

Being tested
Bapotulimab (BAY1905254), Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)
Keywords
HNSCC, Head and Neck Cancer, Immunotherapy, PD1, PDL1, ILDR2, Bapotulimab, Pembrolizumab, Immune checkpoint inhibitor
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bapotulimab (BAY1905254)Drug

    Intravenous administration of escalating doses of Bapotulimab

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

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

Study groups in NCT03666273
Study groupRoleWhat they receive
Dose escalation_MonotherapyExperimentalPatients with solid tumor types considered immunosensitive
Receives: Drug: Bapotulimab (BAY1905254)
Dose escalation_Combination therapyExperimentalPatients with solid tumor types considered immunosensitive
Receives: Drug: Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)
Expansion HNSCC_Combination therapyExperimentalPatients with head and neck squamous cell carcinoma (HNSCC)
Receives: Drug: Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

    Measured: Up to 58 months

  3. Cmax of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg

    Maximum plasma concentration after single dose

    Measured: Up to 504 hours after drug in Cycle 1

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

    Area under the plasma concentration curve after single dose

    Measured: Up to 504 hours after drug in Cycle 1

  5. Maximum tolerated dose (MTD) of Bapotulimab

    Measured: Up to 58 months

Secondary outcomes (5)

  1. Recommended dose of Bapotulimab for Phase 2

    Measured: Up to 58 months

  2. Cmax,md after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg

    Maximum plasma concentration after multiple doses

    Measured: Up to 504 hours after drug in Cycle 3

  3. AUC after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg

    Area under the plasma concentration curve after multiple doses

    Measured: Up to 504 hours after drug in Cycle 3

  4. Incidence of positive anti-drug antibody titer for Bapotulimab

    Measured: Up to 58 months

  5. Best overall response rate

    Determined by RECIST 1.1

    Measured: Up to 58 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2018
  2. Study start12 Sep 2018
  3. Primary completion16 Jun 2023
  4. Study completion15 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03666273
Sponsor's protocol ID
18789
Other IDs
MK-3475-920, KEYNOTE-920, 2018-000990-63, 2018
Status last verified
May 2024
First submitted
10 Sep 2018
Last updated
28 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bapotulimab (BAY1905254) and Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®) in people with Advanced Solid Tumor and Head and Neck Squamous Cell Carcinoma, run by Bayer at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03666273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

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