Trial · NCT05372640
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
NCT05372640, Phase 1, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors. Trials, record NCT05372640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05372640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
- NCT number
- NCT05372640
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 45 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic NUT Carcinoma, Unresectable Breast Carcinoma, Unresectable Malignant Solid Neoplasm, Unresectable NUT Carcinoma
- Interventions
- Abemaciclib, BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure, Biospecimen Collection, Diagnostic Imaging Testing
- First posted
- 2022-05-13
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose or recommended phase 2 dose (Phase I dose escalation) | During the first cycle of therapy (28 days) | The toxicity of the combination will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v). 5.0 criteria. |
| Primary | Incidence of adverse events (Phase I dose expansion) | Up to 5 years | Safety will be reported with descriptive statistics. Toxicity will be graded according to National Cancer Institute CTCAE, v5.0. Toxicities will be summarized by maximum grade and by treatment arm. Incidence rate of each toxicity will be reported with 95% exact confidence intervals. |
| Primary | Overall response rate (Phase I dose expansion) | Up to 5 years | Will be graded as complete response (CR), partial response (PR), stable disease (SD) and progressive disease. |
| Primary | Clinical benefit rate (CBR) (Phase I dose expansion) | Up to 5 years | Clinical benefit is defined as CR, PR or SD \>= 24 weeks according to Response Evaluation Criteria in Solid Tumors 1.1. CBR will be reported with 90% exact confidence intervals. |
| Primary | Duration of response (DoR) (Phase I dose expansion) | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | Median DoR will be reported with ranges. |
| Primary | Time to response (Phase I dose expansion) | From the time initiation of therapy to the time measurement criteria are met for CR or PR (whichever is first recorded), assessed up to 5 years | |
| Primary | Overall survival (Phase I dose expansion) | From study enrollment until death due to any cause, assessed up to 5 years | |
| Primary | Progression free survival (Phase I dose expansion) | From study enrollment until the identification of disease progression or death, assessed up to 5 years | |
| Secondary | Pharmacokinetics (PK) | Up to 5 years | Designed the PK sampling to enable simultaneous estimation of individual pharmacokinetic parameters of abemaciclib, ZEN003694, and their respective metabolites using nonlinear mixed effects modeling. Will compare the ratio of observed/historical 90% confidence interval of abemaciclib exposure. |
| Secondary | Thymidine kinase (TK) | Up to 5 years | Will compare exposures of abemaciclib and abemaciclib metabolites to TK activity at cycle 1 day 15 and beyond and also change in TK activity versus clinical outcomes. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
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 |
|---|---|---|---|---|---|
| UM1CA186709 | Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site) | SHAPIRO, GEOFFREY I.; FLAHERTY, KEITH T; KUFE, DONALD W. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05372640
GET https://conductscience.org/api/trials/v1/NCT05372640/registered