Trials / Recruiting
RecruitingNCT06805617
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- Sponsor
- Glenn J. Hanna · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Detailed 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 (MRI) scans, or Positron Emission (PET) scans Computerized, blood tests, urine tests, and tumor biopsies. Participants will be in this study for approximately 3 years including follow-up after active study treatment. It is expected that about 35 people will take part in this research study. Summit Therapeutics, a pharmaceutical company, is supporting this research study by providing funding for the research and the study drug.
Conditions
- Salivary Gland Cancer
- Advanced Salivary Gland Carcinoma
- Metastatic Salivary Gland Cancer
- Adenoid Cystic Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ivonescimab | An immunoglobulin (Ig) G1 monoclonal antibody (mAb), single-use vial, via intravenous (into the vein) infusion per protocol. |
Timeline
- Start date
- 2025-02-26
- Primary completion
- 2026-07-01
- Completion
- 2027-07-01
- First posted
- 2025-02-03
- Last updated
- 2025-07-29
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06805617. Inclusion in this directory is not an endorsement.