Trial · NCT07007559
ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
NCT07007559, Phase 2, Recruiting, ALX Oncology Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer. Trials, record NCT07007559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07007559
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
- NCT number
- NCT07007559
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- ALX Oncology Inc.
- Conditions
- Breast Cancer, Metastatic
- Interventions
- Evorpacept (ALX148), Trastuzumab, Paclitaxel, Capecitabine, Eribulin, Gemcitabine, Vinorelbine
- First posted
- 2025-06-06
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment | Approximately 6 months after the last participant is enrolled | Evaluate the ORR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). ORR is defined as a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST v1.1 based on BICR assessment. |
| Secondary | Overall Response Rate (ORR) based on Investigator assessment | Approximately 6 months after the last participant is enrolled | Evaluate the ORR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). ORR is defined as a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) based on Investigator Assessment. |
| Secondary | Clinical Benefit Rate (CBR) using RECIST v1.1 based on BICR and Investigator assessment | Approximately 6 months after the last participant is enrolled | Evaluate the CBR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). CBR is defined as the proportion of participants whose BOR is confirmed PR, confirmed CR, or SD with duration \>6 months using RECIST v1.1 based on BICR and Investigator assessment. |
| Secondary | Duration of Response (DoR) using RECIST v1.1 based on BICR and Investigator assessment | Approximately 6 months after the last participant is enrolled | Evaluate the DoR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). DoR is measured from the time measurement criteria are first met for CR / PR (whichever is first recorded) until documented progressive disease or death from any cause, whichever occurs first using RECIST v1.1 based on BICR and Investigator assessment. |
| Secondary | Progression-Free Survival (PFS) using RECIST v1.1 based on BICR and Investigator assessment | Approximately 6 months after the last participant is enrolled | Evaluate the PFS of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). PFS is measured from the date of enrollment until documented progressive disease or death from any cause, whichever occurs first, using RECIST v1.1 based on BICR and Investigator assessment |
| Secondary | Overall Survival (OS) | Approximately 6 months after the last participant is enrolled | Evaluate the OS of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). OS is defined as the time from the date of enrollment until death. |
| Secondary | Number of participants with adverse events (AEs) and with laboratory abnormalities | Enrollment to 28 days after the last administration of the study drug | AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study drug. Laboratory abnormalities as characterized by type, frequency, severity, and timing. |
| Secondary | Maximum Concentration (Cmax) | Approximately 6 months after the last participant is enrolled | To evaluate the Cmax of evorpacept |
| Secondary | Time at Maximum Concentration (Tmax) | Approximately 6 months after the last participant is enrolled | To evaluate the Tmax of evorpacept |
| Secondary | Area under the Concentration-Time Curve (AUC) | Approximately 6 months after the last participant is enrolled | To evaluate the AUC of evorpacept |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Grants0
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.
None in this release.
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/NCT07007559
GET https://conductscience.org/api/trials/v1/NCT07007559/registered