Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer

Summary

This phase I trial identifies the best dose, possible benefits and/or side effects of BAY 1895344 in combination with chemotherapy in treating patients with solid tumors or urothelial cancer that has spread to other places in the body (advanced). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cisplatin and gemcitabine are chemotherapy drugs that stop the growth of tumor cells by killing the cells. Combining BAY 1895344 with chemotherapy treatment (cisplatin, or cisplatin and gemcitabine) may be effective for the treatment of advanced solid tumors, including urothelial cancer.

Conditions

• Advanced Bile Duct Carcinoma
• Advanced Breast Carcinoma
• Advanced Cervical Carcinoma
• Advanced Endometrial Carcinoma
• Advanced Esophageal Carcinoma
• Advanced Gastric Carcinoma
• Advanced Head and Neck Carcinoma
• Advanced Lung Non-Small Cell Carcinoma
• Advanced Lung Small Cell Carcinoma
• Advanced Malignant Solid Neoplasm
• Advanced Ovarian Carcinoma
• Advanced Penile Carcinoma
• Advanced Pleural Malignant Mesothelioma
• Advanced Urothelial Carcinoma
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Clinical Stage III Gastric Cancer AJCC v8
• Clinical Stage IV Gastric Cancer AJCC v8
• Stage III Cervical Cancer AJCC v8
• Stage III Distal Bile Duct Cancer AJCC v8
• Stage III Intrahepatic Bile Duct Cancer AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage III Penile Cancer AJCC v8
• Stage III Pleural Diffuse Malignant Mesothelioma AJCC v8
• Stage IV Cervical Cancer AJCC v8
• Stage IV Distal Bile Duct Cancer AJCC v8
• Stage IV Intrahepatic Bile Duct Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Penile Cancer AJCC v8
• Stage IV Pleural Diffuse Malignant Mesothelioma AJCC v8
• Triple-Negative Breast Carcinoma
• Unresectable Urothelial Carcinoma

Interventions

DRUG

Cisplatin

Given IV

DRUG

Elimusertib

Given PO

DRUG

Gemcitabine Hydrochloride

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Mamta Parikh · City of Hope Comprehensive Cancer Center LAO

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-25

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations