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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:September 12, 2018
End Date:July 14, 2023
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+)1-888-8422937

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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

The main purpose of this clinical study is to determine the most appropriate dose of the
study medication that can be safely given to subjects, and to look at how the study
medication is changed and distributed by the body.


Inclusion Criteria:

- Male or female patients aged ≥ 18 years.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

- Patients with following histologically confirmed, advanced solid tumors are eligible:

- Dose escalation: all solid tumor types with a likelihood of sensitivity to
immunotherapy, as judged by the investigator.

- Tumor type-specific high-dose (at MTD or MAD(Maximum administered dose))
expansion cohorts: urothelial cancer, HNSCC and cervical cancer.

--- TMB (Tumor mutational burden) enrichment phase only: each tumor type-specific
expansion cohort will be enriched with at least 6 patients with medium-to-high
TMB (≥ 10 mutations/Mb).

- Tumor type-specific low-dose expansion cohort (optional): any tumor type based on
data from dose escalation and expansion indicating pharmacodynamics effect.

- Provision of archival tumor tissue at screening is mandatory.

- 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.

- All dose expansion cohorts: willingness to undergo paired biopsy of tumor.

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. Prior treatment with other
immune-checkpoint inhibitors is acceptable if patients are in disease progression
according to response evaluation criteria in solid tumors (RECIST) 1.1.
We found this trial at
7
sites
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Chicago, Illinois 60637
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Dallas, Texas 75246
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Detroit, Michigan 48202
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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San Antonio, TX
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