A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers
A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers (I-MAC)
Sponsor: Glenn J. Hanna + Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Objective Response Rate (ORR)
Time frame: Up to 2 years
Secondary Endpoints
Median Progression-Free Survival (PFS)
Median Overall Survival (OS)
Duration of Response (DOR)
Eligibility Criteria
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…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →