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Clinical trialNCT04514497Active, not recruitingPhase 1Interventional

Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer

SponsorNational Cancer Institute (NCI)Enrollment29Metastatic Lung Small Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic Neuroendocrine CarcinomaMetastatic Pancreatic AdenocarcinomaStage III Lung Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8+6 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase I trial tests the safety, side effects and best dose of BAY 1895344 when given together with usual chemotherapy (irinotecan or topotecan) in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), with a specific focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding BAY 1895344 to irinotecan or topotecan may be safe and tolerable in treating patients with advanced solid tumors.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, United States

  • Uc Irvine Health/chao Family Comprehensive Cancer Center

    Orange, California, United States

  • Yale University

    New Haven, Connecticut, United States

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, United States

  • University of Kansas Clinical Research Center

    Fairway, Kansas, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, United States

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, United States

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, United States

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, United States

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, United States

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, United States

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, United States

  • University of Kansas Cancer Center - Lee'S Summit

    Lee's Summit, Missouri, United States

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, United States

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, United States

  • Siteman Cancer Center-South County

    St Louis, Missouri, United States

  • Washington University School of Medicine

    St Louis, Missouri, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, United States

  • Upmc Hillman Cancer Center

    Pittsburgh, Pennsylvania, United States

  • Vanderbilt University/ingram Cancer Center

    Nashville, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
20 Oct 2021
Primary completion
15 Feb 2025
Completion
4 Mar 2027
Last update posted
31 Jul 2026
Registered enrollment
29
Registry id
NCT04514497

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.