NCT07134556

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer
• PDL-1 Positive

Interventions

Type	Name	Description
DRUG	Zimberelimab (AB122)	Patients will receive zimberelimab as an IV at a dose of 360 mg on D1 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.
DRUG	Domvanalimab (DOM)	Patients will receive domvanalimab as an IV at a dose of 1200 mg on D1 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.
DRUG	Sacituzumab Govitecan (SG)	Patients will receive sacituzumab govitecan as an IV at a dose of 10 mg/kg on D1 and D8 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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-05-28
• Completion: 2028-12-28
• First posted: 2025-08-21
• Last updated: 2026-01-23