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)
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 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.
Parallel
Ivonescimab
DrugAn immunoglobulin (Ig) G1 monoclonal antibody (mAb), single-use vial, via intravenous (into the vein) infusion per protocol.
Objective Response Rate (ORR)
ORR was defined as the percentage of participants achieving complete response (CR) and partial response (PR) on treatment based on RECIST v1.1 criteria.
Median Progression-Free Survival (PFS)
Progression-Free Survival (PFS) based on Kaplan-Meier method is defined as the time from registration to the earlier of first progression, or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
Median Overall Survival (OS)
Overall Survival (OS) based on Kaplan-Meier method is defined as the time from registration to death due to any cause or censored at date last known alive.
Duration of Response (DOR)
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
Duration of Response [Cohort 1]
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
Click on the lead sponsor to view all of their trials.
Glenn J. Hanna
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Summit Therapeutics
Collaborator
