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 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
- 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
- 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.
- 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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Bayer Study Director
Role: Study Director
Name: Bayer Clinical Trials Contact
|University of Southern California
Los Angeles, California 90033
|Yale University School of Medicine
New Haven, Connecticut 06510
|University of Chicago Hospitals
Chicago, Illinois 60637
|Henry Ford Health System
Detroit, Michigan 48202
|Texas Oncology, PA
Dallas, Texas 75246
|University of Texas MD Anderson Cancer Center
Houston, Texas 77030
|South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229