Trial · NCT07007559
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| Secondary | Clearance (CL) | Approximately 6 months after the last participant is enrolled | To evaluate the CL of evorpacept |
| Secondary | Terminal elimination half-life (t1/2) | Approximately 6 months after the last participant is enrolled | To evaluate the t1/2 of evorpacept |
| Secondary | Evaluate the immunogenicity of evorpacept | Approximately 6 months after the last participant is enrolled | Measured by presence of human serum ADA (anti-evorpacept antibodies) |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07007559/registered