A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers (I-MAC)
Glenn J. Hanna
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)
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 (…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- DrugIvonescimab
An immunoglobulin (Ig) G1 monoclonal antibody (mAb), single-use vial, via intravenous (into the vein) infusion per protocol.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts