Exclusion criteria
vitiligo, HIV or history of AIDS.Known history of, malignancy, non-melanoma skin cancer, unstable angina, psychiatric, active infection, autoimmune disease, trauma, gastrointestinal bleeding, hepatitis B or hepatitis C infection, psoriasis, Dementia, SARS-CoV-2 infection, infection, hypersensitivity, prostate cancer, pneumonitis, cardiac arrhythmias, pneumonia, leptomeningeal disease, Stroke, Grave’s disease, myocarditis, gastrointestinal perforation, Myocarditis, primary CNS lymphoma
VITILIGO, CARDIOVASCULAR DISEASE, UNSTABLE ANGINA, HEART, AUTOIMMUNE DISEASE, CHILDHOOD ATOPIC DERMATITIS, GASTROINTESTINAL BLEEDING, DIVERTICULITIS, PSORIASIS, PERICARDIAL EFFUSION, REMISSION, CNS METASTASES, SYSTEMIC FUNGAL INFECTION, HEPATITIS B, INFLUENZA, SARS-COV-2 INFECTION, TYPE 1 DIABETES MELLITUS, INFECTION, HEPATITIS C, ACUTE PANCREATITIS, HYPERSENSITIVITY, CONGESTIVE HEART FAILURE, PROSTATE CANCER, PNEUMONITIS, UNCONTROLLED HYPERTENSION, METASTASIS, CARDIAC ARRHYTHMIAS, PNEUMONIA, STROKE, TRANSIENT ISCHEMIC ATTACK, VIRUS, DISEASE, CORD COMPRESSION, MYOCARDITIS, MELANOMA IN SITU, MYOCARDIAL INFARCTION, GASTROINTESTINAL PERFORATION, CERVICAL CARCINOMA IN SITU, SQUAMOUS INTRAEPITHELIAL LESION, MYOCARDITIS, GASTROINTESTINAL DISORDERS, PRIMARY CNS LYMPHOMA

Patients with symptomatic CNS metastases. Patients with a history of prior CNS metastasis must have been treated, must be asymptomatic and must not have any of the following at the time of enrollment:No concurrent treatment for the CNS disease (for example, surgery, radiation and corticosteroids >10 mg prednisone per day or equivalent).No progression of CNS metastases on magnetic resonance imaging (MRI) or computed tomography (CT) for at least 14 d after last day of prior therapy for the CNS metastases.No concurrent leptomeningeal disease or cord compression.Patients with primary CNS lymphoma are not eligible.History of prior allogeneic bone marrow, stem cell or solid organ transplantation.Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years) and patients with a history of Grave’s disease that are now euthyroid clinically and by laboratory testing. Patients with type 1 diabetes mellitus are excluded.Treatment with any systemic chemotherapy within 3 weeks before the initiation of study drug administration. Treatment with biologics or any investigational therapy within the 4 weeks before the initiation of study drug administration.Patients who have received prior therapy with a combination of mAbs against PD-1 and LAG-3 will be excluded in the expansion phase.Treatment with radiation therapy within 2 weeks before the initiation of study drug administration.Treatment with systemic corticosteroids (>10 mg per day prednisone or equivalent) or other immune-suppressive drugs within the 14 d before initiation of study drug administration. Steroids for topical ophthalmic, inhaled or nasal administration are allowed. Physiological replacement with hydrocortisone up to 40 mg per day (or equivalent) is allowed.Clinically important cardiovascular disease, including, but not limited to:Myocardial infarction or unstable angina within the 6 months before the initiation of study drug.Stroke or transient ischemic attack within 6 months before the initiation of study drug.Clinically important cardiac arrhythmias.Uncontrolled hypertension: systolic blood pressure (SBP) >180 mmHg, diastolic blood pressure (DBP) >100 mmHg.Congestive heart failure (New York Heart Association class III–IV).Pericarditis or clinically important pericardial effusion.Myocarditis or history of myocarditis.QT interval corrected for heart rate using Fridericia’s formula (QTcF) prolongation >480 ms.HER2Clinically important pulmonary compromise, including, but not limited to, pneumonia or a requirement for continuous supplemental oxygen use to maintain adequate oxygenation.Presence of active pneumonitis or history of non-infectious pneumonitis.Clinically important gastrointestinal disorders, including:Any history of gastrointestinal perforation unless the affected area has been deemed by the investigator to no longer be a risk for perforation.History of clinically important gastrointestinal bleeding within 4 weeks before the initiation of study drug.History of acute pancreatitis within 4 weeks before the initiation of study drug.Diverticulitis that is clinically important in the opinion of the investigator based on the extent or severity of known disease and/or the occurrence of clinically important disease flares within 4 weeks before the initiation of study drug administration.Evidence of active viral, bacterial or systemic fungal infection requiring parenteral treatment within 7 d before the initiation of study drug. Patients requiring any systemic antiviral, antifungal or antibacterial therapy for active infection must have completed treatment no less than 1 week before the initiation of study drug.Known history of positive testing for HIV or history of AIDS.Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen or hepatitis C PCR. This exclusion will not apply to patients with HCC.Secondary primary invasive malignancy that has not been in remission for more than 2 years, except non-melanoma skin cancer, cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Pap smear, localized prostate cancer (Gleason score <6) or resected melanoma in situ.History of trauma or major surgery within 4 weeks before the initiation of study drug administration.Any serious underlying medical or psychiatric condition that would impair the ability of the patient to receive or tolerate the planned treatment at the study site.Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in tebotelimab drug product formulation.Vaccination with any live virus vaccine within 4 weeks before the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.Dementia or altered mental status that would preclude understanding and rendering of informed consent.Prisoners or other individuals who are involuntarily detained.Any investigative site personnel directly affiliated with this study.Any issue that, in the opinion of the investigator, would contraindicate the patient’s participation in the study or confound the results of the study.Confirmed or presumed coronavirus disease 2019 (COVID-19)/severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Although SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines and standards. Patients with a positive test result for SARS-CoV-2 infection, known asymptomatic infection or presumed infection are excluded. Patients may be considered eligible after a resolved SARS-CoV-2 infection once he or she remains afebrile for at least 72 h and after other SARS-CoV-2-related symptoms have fully recovered to baseline for a minimum of 72 h.