Actively Recruiting
A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers (I-MAC)
Led by Glenn J. Hanna · Updated on 2025-07-29
35
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
G
Glenn J. Hanna
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Ivonescimab, an antibody treatment, in adults with advanced, metastatic salivary gland cancers that cannot be cured. This phase 2, open-label study focuses on participants with recurrent or metastatic salivary gland carcinomas, including adenoid cystic carcinoma. Ivonescimab is not yet approved by the FDA for this cancer but has been used for lung cancer treatment. The study is supported by Summit Therapeutics and led by Glenn J. Hanna. Participants receive Ivonescimab through intravenous infusion once daily on day 1 of each 21-day cycle. The study involves two cohorts: one with adenoid cystic carcinoma and one with other salivary gland carcinomas. About 11 participants will enroll in each cohort initially; if more than two respond to treatment, enrollment continues. Imaging tests occur every 9 weeks, followed by an end-of-treatment visit and imaging. After treatment ends, participants have follow-up visits every 12 weeks. During the study, participants undergo screening, clinic visits, imaging tests such as X-rays, CT, MRI, or PET scans, blood and urine tests, and tumor biopsies. Researchers will measure the objective response rate over up to 2 years and monitor progression-free survival, overall survival, duration of response, safety, and toxicity. The total participation time is approximately 3 years, including follow-up after treatment completion to observe long-term outcomes.
CONDITIONS
Brief Title
A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically confirmed salivary gland carcinoma, including adenoid cystic carcinoma, with recurrent, metastatic, or advanced unresectable disease
- Willing to provide tumor tissue from a biopsy or prior surgery if safe
- Age 18 years or older at consent; no upper age limit
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Meet specified organ and marrow function requirements within 14 days before study registration
- Have documented new or progressive lesion on imaging or new/worsening disease symptoms within 12 months prior to registration
- Have at least one measurable non-CNS lesion of 1 cm or larger by CT or MRI
- At least 2 weeks since prior chemotherapy or biological agents (3 weeks for anti-cancer monoclonal antibody regimens) with recovery from toxicity
- Ability to understand and sign informed consent
- Female participants of childbearing potential must have negative pregnancy tests before registration and before first dose
- Agree to use effective contraception during screening and for 120 days after last dose if applicable
- Male participants with female partners of childbearing potential must also agree to use contraception during the same period
You will not qualify if you...
- Have active central nervous system metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Receiving other cancer therapies or investigational agents during this study
- Have uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, or arrhythmias
- Pregnant or breastfeeding women
- Have other progressing malignancies requiring active treatment, with some exceptions
- Have significant autoimmune conditions or on high-dose corticosteroids
- Recent major surgery or serious trauma within 4 weeks before therapy or planned major surgery within 4 weeks after first dose
- History of bleeding disorders or significant bleeding events within 4 weeks before therapy
- Uncontrolled high blood pressure after treatment
- History of major diseases affecting heart, gastrointestinal tract, or vascular system within specified recent timeframes
- Imaging showing major blood vessel invasion or tumor cavitation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive Ivonescimab by intravenous infusion in 21-day cycles. Imaging tests are performed every 9 weeks to assess treatment response.
Baseline visit and imaging every 9 weeks during treatment
Duration - Up to approximately 3 years including follow-up after treatment
Participants are monitored every 12 weeks after completing treatment to assess long-term outcomes and safety.
Visits every 12 weeks
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
G
Glenn J Hanna, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here