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Elimusertib / Computed Tomography / Metastatic Lung Small Cell Carcinoma · Phase 1 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration documenting a planned dose-escalation and expansion study of BAY 1895344 (elimusertib) combined with chemotherapy in advanced solid tumors. No results have been posted in this registry record; the study is designed to establish maximum tolerated dose and safety profile, not efficacy.
Phase 1, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Neuroendocrine Carcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III…; age from 18 Years. Intervention: Cohort I (elimusertib, irinotecan); Cohort II (elimusertib, irinotecan); Cohort III (elimusertib, topotecan). n = 29. 23 sites: United States.
This is a Phase 1 trial registration documenting a planned dose-escalation and expansion study of BAY 1895344 (elimusertib) combined with chemotherapy in advanced solid tumors. No results have been posted in this registry record; the study is designed to establish maximum tolerated dose and safety profile, not efficacy.
Primary outcomes are safety and maximum tolerated dose, not clinical efficacy or survival. Recruitment status indicates enrolment is complete, but no safety or toxicity data are provided in this record.
This is an early-phase safety trial. Clinicians should not draw conclusions about efficacy or clinical benefit until Phase 1 recruitment and analysis are complete and results are published. The study is designed to inform dosing for future efficacy trials.
Phase 1 dose-escalation trial with 29 enrolled participants testing safety and maximum tolerated dose; no efficacy results reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This is an early-phase safety trial. Clinicians should not draw conclusions about efficacy or clinical benefit until Phase 1 recruitment and analysis are complete and results are published. The study is designed to inform dosing for future efficacy trials.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04514497). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 29 participants (ACTUAL). Conditions: Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Neuroendocrine Carcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III Lung Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Lung Small Cell Carcinoma, Unresectable Malignant Solid Neoplasm, Unresectable Neuroendocrine Carcinoma, Unresectable Pancreatic Adenocarcinoma. Interventions: PROCEDURE: Biopsy Procedure; PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; DRUG: Elimusertib; DRUG: Irinotecan Hydrochloride; PROCEDURE: Magnetic Resonance Imaging; DRUG: Topotecan Hydrochloride. Primary outcome measures: Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Elimursertib , Up to 21 days (first treatment cycle); Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Irinotecan , Up to 21 days (first treatment cycle); Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Topotecan , Up to 21 days (first treatment cycle); Occurrence of Grade 4 Hematologic AEs (Dose Expansion Phase) , Up to 6 months post-treatment. Brief summary: 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.
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