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NCT06805617PHASE2RECRUITING

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.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Salivary Gland Cancer, Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland Cancer, Adenoid Cystic Carcinoma
Interventions
Ivonescimab
Enrollment
35 participants
Primary completion
Jul 2026
Study completion
Jul 2027
First posted
Feb 2025
Last updated
Jul 2025

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.

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Source

Open on ClinicalTrials.gov