Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
Study NCT ID:
NCT06631092
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2024-10-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer
Sponsor:
NEC Bio B.V
Organization:
Study Overview
Official Title:
An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 as add-on to First-line Neoadjuvant Anti-PD-1 Monoclonal Antibody Therapy in Patients With Triple-negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I/II, multicenter, open-label, single-arm trial in triple-negative breast cancer patients under first-line neoadjuvant therapy with approved standard of care anti-PD-1 monoclonal antibody (PD-1 inhibitor), epirubicin/cyclophosphamide chemotherapy, and nab-paclitaxel therapy. NECVAX-NEO1 treatment in addition to standard of care anti-PD1 monoclonal antibody therapy can be prolonged after breast cancer surgery for another 24 weeks, according to the investigator's decision taking into consideration the study patient's health status.
Detailed Description:
Phase I/II, multicenter, open-label, single-arm trial in triple-negative breast cancer patients under first-line neoadjuvant therapy with approved standard of care anti-PD-1 monoclonal antibody (PD-1 inhibitor), epirubicin/cyclophosphamide chemotherapy, and nab-paclitaxel therapy. Optionally, NECVAX-NEO1 treatment in addition to standard of care anti-PD1 monoclonal antibody therapy can be prolonged after breast cancer surgery for another 24 weeks, according to the investigator's decision taking into consideration the study patient's health status.
Personalized NECVAX-NEO1 constructs containing an eukaryotic expression plasmid encoding a series of selected neoantigen epitopes will be manufactured for administration as a patient-specific investigational medicinal product (IMP). The IMP will be administered and as an add-on therapy to the standard of care PD-1 inhibitor therapy.
The trial will consist of mainly:
* A Screening and Induction period of up to 12 weeks, including the neoantigen selection and manufacturing phase, and first-line treatment with PD-1 inhibitor therapy with epirubicin 90 mg/m2/cyclophosphamide 600 mg/m2 every 3 weeks combined with pembrolizumab 200 mg as standard of care treatment,
* A Treatment period of up to 12 weeks with prime and booster administrations of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor pembrolizumab 200 mg every 3 weeks and nab-paclitaxel 125 mg/m2 once a week for 12 weeks up to planned tumor surgery,
* An optional prolongation of booster administration of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor up to 24 weeks, and
* A Follow-up period of 4 weeks, with an End of Treatment (EoT) visit at Week 16 or at Week 40 (in case of the optional treatment prolongation).
* A long-term safety follow-up period (observation period) after EoT for up to 24 months.
Personalized NECVAX-NEO1 constructs containing an eukaryotic expression plasmid encoding a series of selected neoantigen epitopes will be manufactured for administration as a patient-specific investigational medicinal product (IMP). The IMP will be administered and as an add-on therapy to the standard of care PD-1 inhibitor therapy.
The trial will consist of mainly:
* A Screening and Induction period of up to 12 weeks, including the neoantigen selection and manufacturing phase, and first-line treatment with PD-1 inhibitor therapy with epirubicin 90 mg/m2/cyclophosphamide 600 mg/m2 every 3 weeks combined with pembrolizumab 200 mg as standard of care treatment,
* A Treatment period of up to 12 weeks with prime and booster administrations of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor pembrolizumab 200 mg every 3 weeks and nab-paclitaxel 125 mg/m2 once a week for 12 weeks up to planned tumor surgery,
* An optional prolongation of booster administration of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor up to 24 weeks, and
* A Follow-up period of 4 weeks, with an End of Treatment (EoT) visit at Week 16 or at Week 40 (in case of the optional treatment prolongation).
* A long-term safety follow-up period (observation period) after EoT for up to 24 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-512520-11-00 | CTIS | None | View |