# 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

> **NCT04491942** · PHASE1 · ACTIVE_NOT_RECRUITING · sponsor: **National Cancer Institute (NCI)** · enrollment: 74 (estimated)

## Conditions studied

- 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
- **DRUG:** Elimusertib
- **DRUG:** Gemcitabine Hydrochloride

## Key facts

- **NCT ID:** NCT04491942
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-08-25
- **Primary completion:** 2026-06-30
- **Final completion:** 2026-06-30
- **Target enrollment:** 74 (ESTIMATED)
- **Last updated:** 2026-04-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04491942

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04491942, "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". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04491942. Licensed CC0.

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