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

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

INTRODUCTION

  • Org Study ID: 18789
  • Secondary ID: MK-3475-920, 2018-000990-63
  • NCT ID: NCT03666273
  • Sponsor: 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.


  • Overall Status
    Recruiting
  • Start Date
    September 12, 2018
  • Phase
    Phase 1
  • Study Type
    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 - Timeframe: 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 - Timeframe: 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 - Timeframe: 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 - Timeframe: Up to 504 hours after drug in Cycle 1

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

Primary Outcome 5 - Timeframe: Up to 58 months

CONDITION

  • Advanced Solid Tumor

ELIGIBILITY


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.

- TMB-basket expansion cohort of BAY1905254 monotherapy (at MTD or MAD): patients
with medium-to-high TMB from selected solid tumor types with a likelihood of
sensitivity to immunotherapy

- Tumor type-specific high-dose of BAY1905254 monotherapy (at MTD or MAD) expansion
cohorts: urothelial cancer, HNSCC and cervical cancer with medium-to-high TMB.
The pre-planned tumor types may be changed based on data from the TMB-basket
cohort.

- Tumor type-specific high-dose of BAY 1905254 in combination with pembrolizumab
(at MTD or MAD) expansion cohorts: urothelial cancer, HNSCC and Gastric/
Gastroesophageal junction (GEJ) adenocarcinoma.

- Provision of archival tumor tissue at screening is mandatory, except for patients in
the monotherapy TMB-basket expansion cohort.

- 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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bayer Study Director

Role: Study Director

Affiliation: Bayer

Overall Contact

Name: Bayer Study Director

Phone: (+)1-888-8422937

Email: clinical-trials-contact@bayer.com

LOCATION

Facility Status Contact
Facility: Yale University School of Medicine
New Haven, Connecticut 06510
United States 		Status: Recruiting Contact: N/A
Facility: University of Chicago Hospitals
Chicago, Illinois 60637
United States 		Status: Recruiting Contact: N/A
Facility: Henry Ford Health System
Detroit, Michigan 48202
United States 		Status: Recruiting Contact: N/A
Facility: University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States 		Status: Recruiting Contact: N/A
Facility: South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
United States 		Status: Recruiting Contact: N/A

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