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BRIEF TITLE: 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

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


  • Org Study ID: 18789
  • Secondary ID: 2018-000990-63
  • NCT ID: NCT03666273
  • NCT Alias:
  • Sponsor: Bayer - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting September 12, 2018 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - 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)

Primary Outcome 1 - Time Frame: Up to 58 months

Primary Outcome 2 - Measure: Severity of treatment-emergent AEs (TEAEs) including treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and dose-limiting toxicities (DLTs)

Primary Outcome 2 - Time Frame: Up to 58 months

Primary Outcome 3 - Measure: Cmax of BAY1905254 after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg

Primary Outcome 3 - Time Frame: Up to 504 hours after drug in Cycle 1

Primary Outcome 4 - Measure: AUC of BAY1905254 after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg

Primary Outcome 4 - Time Frame: Up to 504 hours after drug in Cycle 1

Primary Outcome 5 - Measure: Maximum tolerated dose (MTD) of BAY1905254

Primary Outcome 5 - Time Frame: Up to 58 months

Condition:

  • Advanced Solid Tumor

Eligibility

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Bayer Study Director

Role: Study Director

Affiliation: Bayer

Overall Contact

Name: Bayer Clinical Trials Contact

Phone: (+)1-888-8422937

Email: clinical-trials-contact@bayer.com

Locations

Facility Status Contact
University of Southern California
Los Angeles, California 90033
United States
Not yet recruiting
Yale University School of Medicine
New Haven, Connecticut 06510
United States
Recruiting
University of Chicago Hospitals
Chicago, Illinois 60637
United States
Recruiting
Henry Ford Health System
Detroit, Michigan 48202
United States
Recruiting
Texas Oncology, PA
Dallas, Texas 75246
United States
Not yet recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
United States
Recruiting