Recruiting soon

ADJUNCTZimberelimab, Domvanalimab and Sacituzumab Govitecan for PD-L1 Positive Advanced Triple-negative Breast Cancer

What is being tested

Zimberelimab (AB122)

+ Domvanalimab (DOM)

+ Sacituzumab Govitecan (SG)

Drug

Who is being recruted

Breast Diseases+4

+ Breast Neoplasms

+ Neoplasms

Over 18 Years

+39 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: March 2026

See protocol details

Summary

Principal SponsorMedSIR

Study ContactMEDSIR MEDSIR

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new treatment method for patients with a specific type of advanced breast cancer known as PD-L1 positive triple-negative breast cancer. This cancer is difficult to treat and does not respond well to traditional therapies. The study focuses on using a combination of three drugs: zimberelimab, domvanalimab, and sacituzumab govitecan, as the first line of treatment. Participants eligible for this trial are adults with this type of cancer who have not previously received systemic treatment for their advanced cancer. This research aims to improve treatment outcomes for a group of patients who currently have limited options. Participants in the study will receive treatment through intravenous infusions. Zimberelimab and domvanalimab are given on the first day of each cycle, with sacituzumab govitecan administered on the first and eighth days, repeated every 21 days. The trial will evaluate how safe and effective this drug combination is by monitoring participants for any side effects, as well as any changes in their cancer. The study will continue until the treatment no longer works, unacceptable side effects occur, or participants choose to stop, providing important data on the potential of these drugs to benefit patients with this challenging condition.

Official TitleA 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

NCT07134556

Principal SponsorMedSIR

Study ContactMEDSIR MEDSIR

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesTriple Negative Breast Neoplasms

Criteria

14 inclusion criteria required to participate

Female or male participants, regardless of race and/or ethnic group, aged 18 years or older, able to understand and give written informed consent form (ICF).

Histologically confirmed TNBC per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 criteria, based on local testing performed on the most recent biopsy in the metastatic setting. . Triple-negative status is defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PgR) and negative for human epidermal growth factor receptor 2 (HER2) (0-1+ by immunohistochemistry or 2+ and negative by in situ hybridization test).

Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.

Measurable disease according to RECIST v.1.1. Tumor lesions situated in a previously irradiated area are considered measurable if unequivocal progression has been documented in such lesions since radiation.

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25 exclusion criteria prevent from participating

Inability to comply with Study and follow-up procedures.

Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.

Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases (except those treated with chemotherapy) may participate if they meet the following criteria: stable CNS disease demonstrated by radiographic stability for at least 4 weeks prior to enrollment, all neurologic symptoms have returned to baseline, no evidence of new or enlarging brain metastases, and clinical stability for at least 2 weeks while taking ≤ 10 mg/day of prednisone or its equivalent. However, all participants with carcinomatous meningitis are excluded regardless of clinical stability.

Requirement for ongoing therapy with any prohibited medications listed in the protocol.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

patients will receive zimberelimab as an intravenous infusion (IV) at a dose of 360 mg on Day 1 (D1); domvanalimab as an IV at a dose of 1200 mg on D1 and sacituzumab govitecan as an IV at a dose of 10 mg/kg on D1 and 8 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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers