Trial · NCT05071209
Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors
NCT05071209, Phase 1, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2026-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors. Trials, record NCT05071209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05071209
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors
- NCT number
- NCT05071209
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Alveolar Rhabdomyosarcoma, Recurrent Ewing Sarcoma, Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm, Refractory Alveolar Rhabdomyosarcoma, Refractory Ewing Sarcoma, Refractory Lymphoma, Refractory Malignant Solid Neoplasm
- Interventions
- Elimusertib
- First posted
- 2021-10-08
- Last updated
- 2026-01-23
- Results first posted
- 2026-01-23
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Cycle 1 Dose Limiting Toxicities for BAY 1895344 (Elimusertib) During Dose Escalation | Up 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). |
| Primary | Response of BAY 1895344 (Elimusertib) | Through study completion, up to 37 months | Frequency (%) of patients with best response of complete response or partial response among response-evaluable patients stratified by Phase 2 cohort. |
| Secondary | Incidence of Adverse Events of BAY 1895344 (Elimusertib) | Through study completion, up to 37 months | Frequency (%) of patients with adverse events stratified by study part and dose level. |
| Secondary | Area Under the Drug Concentration Time Curve of BAY 1895344 (Elimusertib) | Up to 28 days | Median (min, max) of the area under the drug concentration time curve (AUC) in cycle 1 stratified by study part and dose level. |
| Secondary | Change in Phosphorylated (p)ATR of BAY 1895344 (Elimusertib) | Up to 28 days | Median (min, max) of the change in (p)ATR stratified by study part and dose level. |
| Secondary | Change in pH2AX of BAY 1895344 (Elimusertib) | Up to 28 days | Median (min, max) of the change in pH2AX stratified by study part and dose level. |
| Secondary | Change in pKAP1 of BAY 1895344 (Elimusertib) | Up to 28 days | Median (min, max) of the change in pKAP1 stratified by study part and dose level. |
| Secondary | Influence of ALT on Activity of BAY 1895344 | Up to 28 days | Median (min, max) of ALT in responders (CR or PR) versus non-responders among all response-evaluable patients. |
| Secondary | Influence of Tumor Tissue Expression of ATM on Activity of BAY 1895344 | Up to 28 days | Median (min, max) of ATM in responders (CR or PR) versus non-responders among all response-evaluable patients. |
| Secondary | Influence of Tumor Tissue Expression of PGBD5 on Activity of BAY 1895344 | Up to 28 days | Median (min, max) of PGBD5 in responders (CR or PR) versus non-responders among all response-evaluable patients. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Cycle 1 Dose Limiting Toxicities for BAY 1895344 (Elimusertib) During Dose Escalation | Up to 28 days (cycle 1) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Response of BAY 1895344 (Elimusertib) | Through study completion, up to 37 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Adverse Events of BAY 1895344 (Elimusertib) | Through study completion, up to 37 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Area Under the Drug Concentration Time Curve of BAY 1895344 (Elimusertib) | Up to 28 days | Plasma concentrations were not collected for Part B patients as it was optional | hr*ng/mL | MEDIAN |
| SECONDARY | Change in Phosphorylated (p)ATR of BAY 1895344 (Elimusertib) | Up to 28 days | These were tissue-based assays to be performed on paired tissue samples, if available. There was no protocol mandated on study biopsy; tissue was to be available only when obtained for clinical purposes. No on-study tissue was obtained, submitted and available for this analysis | ||
| SECONDARY | Change in pH2AX of BAY 1895344 (Elimusertib) | Up to 28 days | These were tissue-based assays to be performed on paired tissue samples, if available. There was no protocol mandated on study biopsy; tissue was to be available only when obtained for clinical purposes. No on-study tissue was obtained, submitted and available for this analysis | ||
| SECONDARY | Change in pKAP1 of BAY 1895344 (Elimusertib) | Up to 28 days | These were tissue-based assays to be performed on paired tissue samples, if available. There was no protocol mandated on study biopsy; tissue was to be available only when obtained for clinical purposes. No on-study tissue was obtained, submitted and available for this analysis | ||
| SECONDARY | Influence of ALT on Activity of BAY 1895344 | Up to 28 days | |||
| SECONDARY | Influence of Tumor Tissue Expression of ATM on Activity of BAY 1895344 | Up to 28 days | |||
| SECONDARY | Influence of Tumor Tissue Expression of PGBD5 on Activity of BAY 1895344 | Up to 28 days |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Cycle 1 Dose Limiting Toxicities for BAY 1895344 (Elimusertib) During Dose Escalation | Phase 1- Part A/ Dose Level 1 | 0 | Participants | ||
| Frequency of Cycle 1 Dose Limiting Toxicities for BAY 1895344 (Elimusertib) During Dose Escalation | Phase 1-Part PK/ Dose Level 1 | 0 | Participants | ||
| Response of BAY 1895344 (Elimusertib) | Phase 2- Part B1/ Dose Level 1 | 0 | Participants | ||
| Response of BAY 1895344 (Elimusertib) | Phase 2- Part B2/ Dose Level 1 | 0 | Participants | ||
| Response of BAY 1895344 (Elimusertib) | Phase 2- Part B3/ Dose Level 1 | 0 | Participants | ||
| Incidence of Adverse Events of BAY 1895344 (Elimusertib) | Phase 1- Part A/ Dose Level 1 | 8 | Participants | ||
| Incidence of Adverse Events of BAY 1895344 (Elimusertib) | Phase 1- Part PK/ Dose Level 1 | 1 | Participants | ||
| Incidence of Adverse Events of BAY 1895344 (Elimusertib) | Phase 2- Part B1/ Dose Level 1 | 8 | Participants | ||
| Incidence of Adverse Events of BAY 1895344 (Elimusertib) | Phase 2- Part B2/ Dose Level 1 | 9 | Participants | ||
| Incidence of Adverse Events of BAY 1895344 (Elimusertib) | Phase 2- Part B3/ Dose Level 1 | 3 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1- Part A/ Dose Level 1 | 8 | |
| Overall Study | STARTED | Phase 1- Part PK/ Dose Level 1 | 1 | |
| Overall Study | STARTED | Phase 2- Part B1/ Dose Level 1 | 10 | |
| Overall Study | STARTED | Phase 2- Part B2/ Dose Level 1 | 9 | |
| Overall Study | STARTED | Phase 2- Part B3/ Dose Level 1 | 3 | |
| Overall Study | COMPLETED | Phase 1- Part A/ Dose Level 1 | 0 | |
| Overall Study | COMPLETED | Phase 1- Part PK/ Dose Level 1 | 0 | |
| Overall Study | COMPLETED | Phase 2- Part B1/ Dose Level 1 | 0 | |
| Overall Study | COMPLETED | Phase 2- Part B2/ Dose Level 1 | 0 | |
| Overall Study | COMPLETED | Phase 2- Part B3/ Dose Level 1 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events990
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Phase 1- Part A/ Dose Level 1 | 1 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1- Part PK/ Dose Level 1 | 0 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 2- Part B1/ Dose Level 1 | 2 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 2- Part B2/ Dose Level 1 | 1 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 2- Part B3/ Dose Level 1 | 0 | 3 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1- Part A/ Dose Level 1 | 0 | 8 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1- Part PK/ Dose Level 1 | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 2- Part B1/ Dose Level 1 | 1 | 10 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 2- Part B2/ Dose Level 1 | 0 | 9 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 2- Part B3/ Dose Level 1 | 1 | 3 |
1 to 10 of 990Source ClinicalTrials.gov
See all 990 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1- Part A/ Dose Level 1 | 6 | 8 |
| Total, all-cause mortality | Phase 1- Part PK/ Dose Level 1 | 1 | 1 |
| Total, all-cause mortality | Phase 2- Part B1/ Dose Level 1 | 9 | 10 |
| Total, all-cause mortality | Phase 2- Part B2/ Dose Level 1 | 8 | 9 |
| Total, all-cause mortality | Phase 2- Part B3/ Dose Level 1 | 2 | 3 |
| Total, other adverse events | Phase 1- Part A/ Dose Level 1 | 8 | 8 |
| Total, other adverse events | Phase 1- Part PK/ Dose Level 1 | 1 | 1 |
| Total, other adverse events | Phase 2- Part B1/ Dose Level 1 | 10 | 10 |
| Total, other adverse events | Phase 2- Part B2/ Dose Level 1 | 9 | 9 |
| Total, other adverse events | Phase 2- Part B3/ Dose Level 1 | 3 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA228823 | Pediatric Early Phase Clinical Trials Network (PEP-CTN) Transfer Application | FOX, ELIZABETH | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2018 to 2025 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase 1- Part A/ Dose Level 1 vs Phase 1-Part PK/ Dose Level 1: Frequency of Cycle 1 Dose Limiting Toxicities for BAY 1895344 (Elimusertib) During Dose Escalation |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05071209
GET https://conductscience.org/api/trials/v1/NCT05071209/events?page=2