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A First-in-human Study of ILDR2 (Immunoglobulin-like Domain Containing Receptor 2) Function-blocking Antibody BAY1905254

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ClinicalTrials.gov Identifier: NCT03666273
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The main purpose of this clinical study is to determine the most appropriate dose of the study medication that can be safely given to cancer patients alone or in combination with another cancer drug, and to look at how the study medication is changed and distributed by the body.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: BAY1905254 Drug: BAY1905254 + Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 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 : July 14, 2023
Estimated Study Completion Date : July 14, 2023

Arm Intervention/treatment
Experimental: Dose escalation_Monotherapy
Patients with solid tumor types considered immunosensitive
Drug: BAY1905254
Intravenous administration of escalating doses of BAY1905254 (dose escalation) or of maximum tolerated dose (expansion)

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

Experimental: Expansion Urothelial cancer_Monotherapy
Patients with urothelial cancer
Drug: BAY1905254
Intravenous administration of escalating doses of BAY1905254 (dose escalation) or of maximum tolerated dose (expansion)

Experimental: Expansion Urothelial cancer_Combination therapy
Patients with urothelial cancer
Drug: BAY1905254 + Pembrolizumab
Intravenous administration of escalating doses of BAY1905254 (dose escalation) or of maximum tolerated dose (expansion), and of a fixed dose of pembrolizumab

Experimental: Expansion HNSCC_Monotherapy
Patients with had and neck squamous cell carcinoma (HNSCC)
Drug: BAY1905254
Intravenous administration of escalating doses of BAY1905254 (dose escalation) or of maximum tolerated dose (expansion)

Experimental: Expansion HNSCC_Combination therapy
Patients with had and neck squamous cell carcinoma (HNSCC)
Drug: BAY1905254 + Pembrolizumab
Intravenous administration of escalating doses of BAY1905254 (dose escalation) or of maximum tolerated dose (expansion), and of a fixed dose of pembrolizumab

Experimental: Expansion Cervical cancer_Monotherapy
Patients with gastric/ gastroesophageal junction adenocarcinoma
Drug: BAY1905254
Intravenous administration of escalating doses of BAY1905254 (dose escalation) or of maximum tolerated dose (expansion)

Experimental: Expansion Gastric cancer_Combination therapy
Patients with gastric/ gastroesophageal junction adenocarcinoma
Drug: BAY1905254 + Pembrolizumab
Intravenous administration of escalating doses of BAY1905254 (dose escalation) or of maximum tolerated 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 BAY1905254 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 BAY1905254 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 BAY1905254 [ Time Frame: Up to 58 months ]

Secondary Outcome Measures :
  1. Recommended dose of BAY1905254 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 and neutralizing antibody titer for BAY1905254 [ Time Frame: Up to 58 months ]
  5. Best overall response rate [ Time Frame: Up to 58 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Inclusion Criteria:

  • Male or female patients aged ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Patients with following histologically confirmed, advanced or metastatic solid tumors are eligible:

    • Dose escalation: All solid tumor types with a likelihood of sensitivity to immunotherapy, as judged by the investigator.
    • Dose expansion: Patients with urothelial cancer or head and neck squamous cell carcinoma (HNSCC) or cervical cancer or gastric/ gastroesophageal junction adenocarcinoma.
  • Provision of archival tumor tissue at screening is mandatory.
  • All dose expansion cohorts: Willingness to undergo paired biopsy of tumor.
  • 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.

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.

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, California
University of Southern California Not yet recruiting
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, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
United States, Texas
Texas Oncology, PA Not yet recruiting
Dallas, Texas, United States, 75246
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03666273     History of Changes
Other Study ID Numbers: 18789
2018-000990-63 ( EudraCT Number )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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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:
Neoplasm
Immuno oncology drug
Urothelial cancer
Head and neck squamous cell carcinoma (HNSCC)
Cervical cancer
Gastric/ Gastroesophageal junction adenocarcinoma
Additional relevant MeSH terms:
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Pembrolizumab
Antibodies
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents