Trial · NCT05163223
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
NCT05163223, Phase 2, Terminated, Aston Sci. Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer. Trials, record NCT05163223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05163223
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
- NCT number
- NCT05163223
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Aston Sci. Inc.
- Conditions
- Breast Cancer
- Interventions
- AST-301(pNGVL3-hICD), rhuGM-CSF, Placebo, Pembrolizumab, Capecitabine
- First posted
- 2021-12-20
- Last updated
- 2024-06-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-year invasive disease free survival rate (iDFS) | Overall study period approximately up to 4years (End of study in this study is defined as 2years frm the date of last Patient In. | iDFS event is defined as Ipsilateral breast tumor recurrence Local/regional invasive recurrence Distant recurrence Invasive contralateral breast cancer Death (from breast cancer/non-breast cancer cause/unknown cause) Secondary primary invasive cancer (non-breast) |
| Secondary | AST-301 specific T cell immune responses | Up to approximately 82 weeks | Immune response will be assessed by IFN-gamma enzyme-linked immune absorbent spot (ELISpot) assay |
| Secondary | Change in central memory T cell populations | Up to approximately 82 weeks | Assessment by FACS |
| Secondary | Distant Recurrence-Free Survival rate, dRFS rate | Overall study period approximately up to 4 years | dRFS rate at the end of study |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE | Overall study period approximately up to 4years | To assess safety of AST-301 administered in breast cancer patients. |
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.
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/NCT05163223
GET https://conductscience.org/api/trials/v1/NCT05163223/registered