A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers (NCT06805617) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers
United States35 participantsStarted 2025-02-26
Plain-language summary
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)
Who can participate
Age range18 Years
SexALL
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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:
* 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 uri…