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Trial · NCT05071209

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryFrequency of Cycle 1 Dose Limiting Toxicities for BAY 1895344 (Elimusertib) During Dose EscalationUp to 28 days (cycle 1)Frequency (%) of patients experiencing a cycle 1 dose limiting toxicity among toxicity-evaluable patients stratified by dose level during the dose escalation part of the study (Part A).
PrimaryResponse of BAY 1895344 (Elimusertib)Through study completion, up to 37 monthsFrequency (%) of patients with best response of complete response or partial response among response-evaluable patients stratified by Phase 2 cohort.
SecondaryIncidence of Adverse Events of BAY 1895344 (Elimusertib)Through study completion, up to 37 monthsFrequency (%) of patients with adverse events stratified by study part and dose level.
SecondaryArea Under the Drug Concentration Time Curve of BAY 1895344 (Elimusertib)Up to 28 daysMedian (min, max) of the area under the drug concentration time curve (AUC) in cycle 1 stratified by study part and dose level.
SecondaryChange in Phosphorylated (p)ATR of BAY 1895344 (Elimusertib)Up to 28 daysMedian (min, max) of the change in (p)ATR stratified by study part and dose level.
SecondaryChange in pH2AX of BAY 1895344 (Elimusertib)Up to 28 daysMedian (min, max) of the change in pH2AX stratified by study part and dose level.
SecondaryChange in pKAP1 of BAY 1895344 (Elimusertib)Up to 28 daysMedian (min, max) of the change in pKAP1 stratified by study part and dose level.
SecondaryInfluence of ALT on Activity of BAY 1895344Up to 28 daysMedian (min, max) of ALT in responders (CR or PR) versus non-responders among all response-evaluable patients.
SecondaryInfluence of Tumor Tissue Expression of ATM on Activity of BAY 1895344Up to 28 daysMedian (min, max) of ATM in responders (CR or PR) versus non-responders among all response-evaluable patients.
SecondaryInfluence of Tumor Tissue Expression of PGBD5 on Activity of BAY 1895344Up to 28 daysMedian (min, max) of PGBD5 in responders (CR or PR) versus non-responders among all response-evaluable patients.
SecondaryInfluence of Tumor Tissue Expression of R-loops on Activity of BAY 1895344Up to 28 daysMedian (min, max) of R-loops in responders (CR or PR) versus non-responders among all response-evaluable patients.
SecondaryResponse of BAY 1895344 (Elimusertib) in Children < 18 YearsUp to 60 monthsFrequency (%) of patients with best response of complete response or partial response among response-evaluable patients in the dose escalation part of the study (Part A).
SecondaryResponse of BAY 1895344 in Pediatric Patients With Non-CNS Solid Tumors or LymphomasUp to 60 months
Frequency of patients with best response of complete response or partial response among response-evaluable patients with non-CNS solid tumors or lymphomas with specific deleterious alternations in DDR pathway.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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