A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers
{ "Phase 2 Ivonescimab for Advanced Salivary Gland Cancers", "This study is testing a drug called Ivonescimab for people with advanced or metastatic (spread to other parts of the body) salivary gland cancers. Ivonescimab is a type of antibody that is thought to work by blocking or slowing cancer cell growth. While not yet approved for salivary gland cancer, it has been used to treat lung cancer. The study aims to see how well Ivonescimab works and if it is safe. To join, you must have salivary gland cancer that has come back, spread, or cannot be removed by surgery, and be at least 18 years old. The main goal is to see how many people have their tumors shrink or disappear (Objective Response Rate) over a period of up to two years. About 35 people are expected to participate.", "design": "This is a Phase 2, open-label study, meaning both you and your doctors will know you are receiving Ivonescimab. It is not randomized, and about 35 people are expected to participate.", "commitments": "You would have screening visits, in-clinic visits, X-rays, CT scans, MRI scans, PET scans, blood tests, urine tests, and tumor biopsies. You would be in the study for about 3 years, including follow-up after treatment.", "compensation": "Not stated in the trial record.", "follow_up": "You will be followed for approximately 3 years after active study treatment, with the primary outcome measured up to 2 years.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06805617
A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers
Recruiting
PHASE2Ages 18+InterventionalTreatmentGlenn J. HannaInvestigator-initiated
~35 participants
Updated 2025-07-29 on ClinicalTrials.gov
What's tested:Ivonescimab
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Up to 2 years
Conditions
Where it's being run
2 sites across 1 statesMassachusetts2
Study leadership
- Glenn J Hanna, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
Serum total bilirubin (T-bili) ≤1.5× upper limit of normal (ULN); for patients with liver metastases or confirmed/suspected Gilbert syndrome, T-bili ≤3× ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; for patients with liver metastases, AST and ALT ≤5× ULN
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
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:
a. Gastrointestinal bleeding
b. Hemoptysis (defined as coughing up ≥0.5 teaspoon of fresh blood or small blood clots). Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.
c. Significant nasal bleeding/epistaxis (bloody nasal discharge is allowed)
d. Need for therapeutic anticoagulant therapy within 14 days prior to the start of therapy.
Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy.
History of major diseases , specifically:
a. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)
b. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before randomization
c. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to randomization
d. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before randomization
e. History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization
Imaging during the screening period shows that the patient has:
a. Radiologically documented evidence of major blood vessel invasion or encasement by cancer (per the judgment of the treatment investigator)
b. Radiographic evidence of intratumor cavitation (per the judgment of the treating investigator)
What this trial measures
- Objective Response Rate (ORR)Up to 2 years
ORR was defined as the percentage of participants achieving complete response (CR) and partial response (PR) on treatment based on RECIST v1.1 criteria.