Status and phase
Conditions
Treatments
About
The goal of this study is to evaluate the efficacy and safety of Ivonescimab in participants with advanced, metastatic salivary gland cancers.
The name of the study drug involved in this study is:
-Ivonescimab (a type of antibody)
Full description
This is phase 2, open-label, non-randomized study is to investigate Ivonescimab in participants with incurable, recurrent or metastatic salivary gland carcinomas (SGC). Ivonescimab is expected to treat salivary gland cancer by blocking or slowing cancer cell growth
The U.S. Food and Drug Administration (FDA) has not approved Ivonescimab as a treatment for advanced, metastatic salivary gland cancer but it has been used as treatment for lung cancer.
The study procedures include screening for eligibility, in-clinic visits, X-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans Computerized, blood tests, urine tests, and tumor biopsies.
Participants will be in this study for approximately 3 years including follow-up after active study treatment.
It is expected that about 35 people will take part in this research study.
Summit Therapeutics, a pharmaceutical company, is supporting this research study by providing funding for the research and the study drug.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Participants must have histologically confirmed salivary gland carcinoma (any histologic subtype, including ACC) with evidence of recurrent, metastatic, or advanced, unresectable disease.
Willing to provide tumor tissue from a diagnostic biopsy or prior surgery if deemed safe and feasible by the investigator.
Age 18 years or older at the time of consent. There is no upper age limit restriction in an effort to include patients across the lifespan.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Participant must have organ and marrow function as defined below within 14 days prior to study registration:
Absolute neutrophil count (ANC) ≥1000/mcL
Hemoglobin ≥8.5 g/dL (with no blood transfusions within 7 days of start of therapy)
Platelets ≥100,000/mcL
Liver function:
Creatinine Within normal limits, or Creatinine clearance (CrCl) ≥50 mL/min using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by BSA is not required for eGFR)
Urine protein: Urine protein <2+ or 24-hour urine protein quantification <1.0 g
Coagulation:prothrombin time (PT) or international normalized ratio (INR) ≤1.5× ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5× ULN (unless abnormalities are unrelated to coagulopathy or coagulation)
Participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within 12 months prior to study registration (progression of disease over any interval is allowed) and/or new or worsening disease-related symptoms within 12 months prior to study registration. This assessment is performed by the treating investigator. Evidence of progression by RECIST v1.1 criteria is not required.
Participants must have at least one RECIST v1.1 measurable non-CNS based lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥1 cm with CT scans or MR imaging.
Prior systemic therapy: At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (3 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE Version 5.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy). Any number of prior therapies for recurrent/metastatic SGC are permitted except receipt of a prior oral VEGFR TKI or anti-PD-1 therapy; but prior therapy for recurrent/metastatic SGC is not required for participation.
Ability to understand and the willingness to sign a written informed consent document.
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication.
Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of the Ivonescimab.
Unsterilized male patient having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until Day 120 after the last dose of Ivonescimab.
Exclusion criteria
Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment) and have no evidence of new or enlarging brain metastases.
Concurrent administration of other cancer specific therapy or investigational agents during the course of this study is not allowed.
Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Pregnant or lactating women as the effects of the investigational therapy (ivonescimab) on the developing human fetus are unknown.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low- risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.
Existing significant autoimmune conditions. Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded. Patients cannot be on long-term (>4 weeks) corticosteroids at doses exceeding prednisone 10 mg daily (or its equivalent).
Major surgical procedures or serious trauma within 4 weeks prior to starting therapy or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) are permitted.
History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to the start of therapy, including but not limited to:
Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy.
History of major diseases , specifically:
Imaging during the screening period shows that the patient has:
Primary purpose
Allocation
Interventional model
Masking
35 participants in 2 patient groups
Loading...
Central trial contact
Glenn J Hanna, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal