2025-521489-80-00
Not yet recruiting
Phase 2
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 (The ADJUNCT Study)
Medica Scientia Innovation Research S.L.10 sites in 1 country25 target enrollmentStarted: December 9, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Medica Scientia Innovation Research S.L.
- Enrollment
- 25
- Locations
- 10
- Primary Endpoint
- ORR rate defined as the rate of patients with complete response (CR) or partial response (PR) as determined locally by the investigator in accordance RECIST v.1.1
Overview
Brief Summary
To determine the Objective Response Rate (ORR) of treatment with zimberelimab, domvanalimab and sacituzumab govitecan in patients with previously untreated, PD-L1 positive unresectable locally advanced or metastatic TNBC.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •Willingness to provide blood and stool samples at the established time points
- •Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before Study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 6 months after the last dose of Study treatments. Female patients must refrain from egg cell donation and breastfeeding during this same period.
- •Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 6 months after the last administration of the Study drug. Male participants must not donate or bank sperm during this same period
- •ECOG performance status of 0-1
- •Minimum life expectancy of ≥ 12 weeks at screening
- •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).
- •PD-L1 positive status defined as a CPS ≥ 10 determined by the antibody 22C3 PharmDx assay, based on local testing
- •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.
Exclusion Criteria
- •Inability to comply with Study and follow-up procedures
- •Have received prior radiotherapy within 2 weeks of start of Study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A two-week washout period is permitted for palliative radiation to non-CNS disease
- •Major surgical procedure or significant traumatic injury within 14 days before the first dose of Study treatment or anticipation of need for major surgery within the course of the Study treatment
- •Have active chronic inflammatory bowel disease (ulcerative colitis/Crohn’s disease) or gastrointestinal perforation within 6 months of enrollment
- •Have an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following: • Unstable angina pectoris, documented myocardial infarction, or symptomatic CHF ( [NYHA] Class II-IV) within six months prior to Study entry. • Symptomatic pericarditis. • Left ventricular ejection fraction (LVEF) < 55% as determined by MUGA scan or ECHO. • History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia), which is symptomatic or requires treatment (NCI-CTCAE grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia or higher-grade atrioventricular [AV]-block, such as second-degree AV-block Type 2 [Mobitz 2] or third-degree AV-block). Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers will be permitted to enroll. Note: MRI compatibility must be confirmed, with adherence to manufacturer guidelines and supervision by a cardiologist or relevant specialist • QT Interval Corrected by Fridericia’s formula (QTcF) prolongation to > 470 ms (females) or > 450 ms (males) based on average of the screening triplicate 12-lead ECG. • History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes. • Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within three months of the Study enrolment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
- •Have a history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- •Have an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) or are receiving chronic systemic corticosteroids at doses > 10 mg/day prednisone or its equivalent 4 weeks prior to the first dose of study drug. Use of topical, inhalational, intranasal, and intraocular steroids and use as premedication for known hypersensitivity reactions (eg, intravenous [IV] contrast, IV drug infusions) will be permitted. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Additionally, patients who have experienced immune-related adverse events (irAEs) due to prior early-stage PD-L1 treatment and for whom rechallenge with a PD-L1 drug may pose a risk should also be excluded
- •Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
- •Have uncontrolled primary immunodeficiency, known human immunodeficiency virus (HIV) infection
Outcomes
Primary Outcomes
ORR rate defined as the rate of patients with complete response (CR) or partial response (PR) as determined locally by the investigator in accordance RECIST v.1.1
ORR rate defined as the rate of patients with complete response (CR) or partial response (PR) as determined locally by the investigator in accordance RECIST v.1.1
Secondary Outcomes
- PFS, defined as the period from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1.
- OS, defined as the period from treatment initiation to death from any cause.
- CBR, defined as the rate of patients with objective response (CR or PR), or stable disease for at least 24 weeks, as determined locally by the investigator using RECIST v.1.1.
- DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1.
- TTR is defined as the period of time from the date of randomization until the first documentation of CR or PR as determined locally by the investigator using RECIST v.1.1.
- Best percentage of change from baseline in the size of target tumor lesions is defined as the biggest decrease, or smallest increase if no decrease is observed, as determined locally by the investigator using RECIST v.1.1.
Investigators
Alicia Garcia Sanz
Scientific
Medica Scientia Innovation Research S.L.
Study Sites (10)
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