Trial · NCT07137416
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
NCT07137416, Phase 1, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer. Trials, record NCT07137416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07137416
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
- NCT number
- NCT07137416
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 36 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Metastatic HER2-Low Breast Carcinoma, Metastatic HER2-Positive Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Triple-Negative Breast Carcinoma, Unresectable Breast Carcinoma, Unresectable HER2-Low Breast Carcinoma, Unresectable HER2-Positive Breast Carcinoma, Unresectable Hormone Receptor-Positive Breast Carcinoma, Unresectable Malignant Solid Neoplasm, Unresectable Triple-Negative Breast Carcinoma
- Interventions
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test, Multigated Acquisition Scan, Pidnarulex, Radiologic Imaging Procedure, Trastuzumab Deruxtecan
- First posted
- 2025-08-22
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (dose escalation phase) | Up to completion of dose-escalation | The dose escalation will follow a Bayesian Optimal Interval design with a target dose limiting toxicity rate of 25%. |
| Primary | Incidence of adverse events with drug combination at the recommended phase 2 dose (dose expansion phase) | Up to 3 years | |
| Secondary | Tumor response rate | Up to 3 years | Radiological response will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1 criteria and will be graded as complete response (CR), partial response (PR), stable disease (SD), and progressive disease. Response rate (CR + PR) and clinical benefit rate (CR + PR + SD \> 24 weeks) will be summarized by frequencies and percentages, by dose level. |
| Secondary | Plasma concentrations of CX-5461 (pidnarulex) and trastuzumab deruxtecan | Cycle (C) 1 day (D) 1, C1D8, C1D10, C1D15, C2D1, C2D8, C2D10, C2D15 (cycle length = 21 days) | Will measure the plasma concentrations of both CX-5461 (pidnarulex) and deruxtecan over time. Area under the curve, maximum concentration, time to reach maximum concentration, and elimination half-life will be calculated for the two study drugs and summarized by dose level. |
| Secondary | Markers of deoxyribonucleic acid (DNA) damage repair (DDR) | At baseline and on-treatment | The secondary, pharmacodynamic endpoint is to determine markers of DDR in tumor specimens at baseline and on-treatment in patients with advanced HER2-low breast cancer in the dose expansion. For the DDR assay, levels exceeding 4% nuclear area positive (NAP) γH2AX, 4% NAP pNBS1, and 5% cells with ≥ 5 Rad51 nuclear foci indicate a DNA damage activation response. |
Source ClinicalTrials.gov
Outcomes0
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/NCT07137416
GET https://conductscience.org/api/trials/v1/NCT07137416/registered