Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 4:10 AM
Study NCT ID:
NCT07134556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as 1L Therapy for PD-L1 Positive Advanced TNBC
Sponsor:
MedSIR
Organization:
Study Overview
Official Title:
A Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as First-line Therapy for PD-L1 Positive Advanced Triple-negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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:
ADJUNCT
Brief Summary:
The ADJUNCT is a single-arm, phase II clinical trial to evaluate the safety and efficacy of the combination of zimberelimab, domvanalimab and sacituzumab govitecan as first-line therapy for patients with PD-L1 positive advanced or metastatic triple-negative breast cancer.
Detailed Description:
This is a single-arm, phase II clinical trial to evaluate the safety and efficacy of the combination of zimberelimab, domvanalimab and sacituzumab govitecan as first-line therapy for patients with PD-L1 positive advanced or metastatic triple-negative breast cancer. Patients ≥18 years with PD-L1 positive (Combined Positive Score \[CPS\] ≥10, assessed using the PD-L1 IHC 22C3 pharmDx assay) advanced TNBC that is not amenable to treatment with curative intent, who have measurable disease and have not received prior systemic treatment in the advance setting. Patients who have received prior (neo)adjuvant therapies are permitted if the disease-free interval (DFI) is at least 6 months.
Evidence of measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate bone marrow and organ function are mandatory.
Patients will receive zimberelimab as an intravenous infusion (IV) at a dose of 360 mg on Day 1; domvanalimab as an IV at a dose of 1200 mg on Day 1 and sacituzumab govitecan as an IV at a dose of 10 mg/kg on Days 1 and 8 of each 21-day cycle until unacceptable toxicity, disease progression, death, discontinuation from the Study treatment for any other reason or End of Study (EoS), whichever occurs first.
Evidence of measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate bone marrow and organ function are mandatory.
Patients will receive zimberelimab as an intravenous infusion (IV) at a dose of 360 mg on Day 1; domvanalimab as an IV at a dose of 1200 mg on Day 1 and sacituzumab govitecan as an IV at a dose of 10 mg/kg on Days 1 and 8 of each 21-day cycle until unacceptable toxicity, disease progression, death, discontinuation from the Study treatment for any other reason or End of Study (EoS), whichever occurs first.
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-521489-80 | EUDRACT_NUMBER | None | View |