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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

NCT07134556 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Principal Investigators

  • Tim Robinson, BMBS, PhD · University of Bristol, Bristol, England (UK)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-05-28
Completion
2028-12-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07134556 on ClinicalTrials.gov