Ivonescimab for Salivary Gland Cancer

(I-MAC Trial)

Recruiting at 1 trial location

Overseen By Glenn J Hanna, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Glenn J. Hanna

Must not be taking: Corticosteroids, Anticoagulants

Disqualifiers: CNS metastases, Uncontrolled illness, Pregnancy, Autoimmune conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: Up to 2 years

35 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take other cancer-specific therapies or investigational agents during the study.

What makes the drug Ivonescimab unique for treating salivary gland cancer?

Ivonescimab is unique because it represents a novel approach in treating salivary gland cancer, a condition with no standard treatment due to its resistance to conventional therapies. While specific details about Ivonescimab's mechanism are not provided, it is part of a growing interest in targeted therapies, which are generally less toxic and more focused on specific cancer pathways compared to traditional chemotherapy. ^{1 2 3 4 5}

What is the purpose of this trial?

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)

Research Team

Glenn J Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for individuals with advanced, metastatic salivary gland cancers, including adenoid cystic carcinoma. Participants should have a type of cancer that has spread and isn't responding to standard treatments.

Inclusion Criteria

I am fully active or can carry out light work.

At least one RECIST v1.1 measurable non-CNS based lesion

I am willing to give a sample of my tumor for the study.

Exclusion Criteria

I do not have any uncontrolled illnesses.

Concurrent administration of other cancer specific therapy or investigational agents

I have active brain metastases or cancer in my brain's lining.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Ivonescimab in 21-day cycles with imaging tests every 9 weeks

Up to 2 years

Cycle 1 through End of Treatment (21 day cycles), Imaging tests every 9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Follow-up every 12 weeks

Treatment Details

Interventions

• Ivonescimab

Trial Overview The study is testing the safety and effectiveness of Ivonescimab, an antibody designed to target cancer cells in patients with certain types of salivary gland cancers.

Participant Groups

Group I: Cohort 2: Non-Adenoid Cystic Carcinoma Salivary Gland Carcinoma Experimental Treatment 1 Intervention

Approximately 11 participants will be enrolled to this cohort in the first stage of recruitment. If there are ≤2 participants (out of 22) with responses to the therapy, the accrual to the study will be stopped. If there are \>2 participants with response, accrual will continue. Enrolled participants will complete: * Baseline visit * Imaging tests every 9 weeks * Cycle 1 through End of Treatment (21 day cycles) --Day 1: Predetermined dose of Ivonescimab 1x daily. * End of treatment visit with imaging * Follow up: every 12 weeks

Group II: Cohort 1: Adenoid Cystic Carcinoma Experimental Treatment 1 Intervention

Approximately 11 participants will be enrolled to this cohort in the first stage of recruitment. If there are ≤2 participants (out of 22) with responses to the therapy, the accrual to the study will be stopped. If there are \>2 participants with response, accrual will continue. Enrolled participants will complete: * Baseline visit * Imaging tests every 9 weeks * Cycle 1 through End of Treatment (21 day cycles) --Day 1: Predetermined dose of Ivonescimab 1x daily. * End of treatment visit with imaging * Follow up: every 12 weeks

Who Is Running the Clinical Trial?

Glenn J. Hanna

Lead Sponsor

Trials

6

Recruited

160+

Summit Therapeutics

Industry Sponsor

Trials

18

Recruited

4,500+

Findings from Research

Ado-trastuzumab emtansine (T-DM1), a targeted therapy combining trastuzumab and a cytotoxic drug, showed excellent efficacy in treating a patient with HER2-positive parotid gland adenocarcinoma with brain metastasis.

This case suggests that targeting the HER2 pathway with T-DM1 could be a promising systemic chemotherapy option for patients with aggressive salivary gland carcinomas, potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of ado-trastuzumab emtansine (T-DM1) in HER2 positive salivary gland tumour with brain metastasis. Dhamne, N., Koyyala, VPB., Chougule, S., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Systemic therapy for recurrent or metastatic salivary gland malignancies. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Salivary gland adenoid cystic carcinoma: a review of chemotherapy and molecular therapies. [2006]

3. Germany pubmed.ncbi.nlm.nih.gov

[Novel therapeutic approaches for salivary gland carcinomas]. [2022]

4. England pubmed.ncbi.nlm.nih.gov

New concepts of personalized therapy in salivary gland carcinomas. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Role of ado-trastuzumab emtansine (T-DM1) in HER2 positive salivary gland tumour with brain metastasis. [2022]