Amivantamab for Salivary Gland Cancer

Not currently recruiting at 5 trial locations

Overseen By Trisha Wise-Draper, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Trisha Wise-Draper

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: HIV, Cardiovascular disease, Hepatitis, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether amivantamab, a medication, can effectively treat adenoid cystic carcinoma, a cancer often found in the salivary glands. Researchers focus on patients with recurrent or metastatic forms of this cancer. It suits those with confirmed adenoid cystic carcinoma that other treatments cannot cure and who have recently experienced disease progression. Participants must have measurable cancer, and those with treated brain metastases may join if no new progression exists. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or immunotherapy within 4 weeks before starting the study, and a 30-day break from any previous investigational drugs is required.

Is there any evidence suggesting that amivantamab is likely to be safe for humans?

Research has shown that amivantamab has been tested in other conditions, specifically EGFR-positive non-small cell lung cancer (NSCLC). In these studies, 129 patients received amivantamab, and the treatment was generally well-tolerated. Some patients experienced side effects, but they were mostly mild or manageable.

Common side effects included skin rashes and reactions at the injection site. These are typical for many cancer treatments and are usually not severe. More serious effects were rare. Since this trial is in a middle phase, researchers have already collected some safety data from earlier studies, which gives them confidence to test it further in new conditions like salivary gland cancer.

Prospective trial participants should discuss potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for salivary gland cancer, which often include surgery, radiation, and chemotherapy, Amivantamab offers a novel approach by targeting specific cancer cell receptors. This experimental drug is a monoclonal antibody that binds to the EGFR and MET receptors on cancer cells, potentially disrupting their growth and survival. Researchers are excited about Amivantamab because it targets these pathways directly, which could lead to more effective treatment outcomes with potentially fewer side effects compared to traditional chemotherapy.

What evidence suggests that amivantamab might be an effective treatment for salivary gland cancer?

Research has shown that amivantamab, the treatment under study in this trial, may help treat recurrent and metastatic adenoid cystic carcinoma, a type of salivary gland cancer. Amivantamab targets two proteins, EGFR and MET, which aid cancer cell growth. By blocking these proteins, the immune system can destroy the cancer cells. In earlier studies, amivantamab caused tumors to shrink in 82% of patients with similar cancers, with 45% of patients showing a positive response overall. These results suggest that amivantamab could be effective for people facing this challenging cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Trisha Wise-Draper, MD,PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for adults (18+) with adenoid cystic carcinoma, which can include non-salivary gland origins. Participants must have measurable disease and be in a stable condition, including those with HIV on effective therapy or treated brain metastases without recent progression. Prior cancers are okay if they don't affect this study's safety or results. People can't join if they've had certain treatments recently, have active hepatitis B/C, serious heart conditions, uncontrolled illnesses, unresolved severe side effects from previous cancer therapies, known allergies to amivantamab components or a history of specific lung diseases.

Inclusion Criteria

Presence of measurable disease as defined by RECIST v1.1

Before enrollment, a participant must be (as defined in Appendix 2: Contraceptive Guidance and Collection of Pregnancy Information)

A participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug.

Exclusion Criteria

My eye condition is stable.

History of allergy or intolerance to study drug components.

I have an ongoing heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter

2 years

Weekly visits for the first cycle, biweekly visits thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Amivantamab

Trial Overview The trial is testing the effectiveness of amivantamab in patients with recurrent and metastatic adenoid cystic carcinoma that cannot be cured by other treatments. Amivantamab is an investigational drug given to see if it can control the growth of cancer cells.

How Is the Trial Designed?

Group I: Amivantamab Experimental Treatment 1 Intervention

Amivantamab weekly for the first cycle and biweekly thereafter.

Amivantamab is already approved in United States, European Union for the following indications:

Approved in United States as Rybrevant for:

• Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
• Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations

Approved in European Union as Rybrevant for:

• Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
• Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations

Who Is Running the Clinical Trial?

Trisha Wise-Draper

Lead Sponsor

Trials

6

Recruited

230+

Published Research Related to This Trial

In a study of six patients with metastatic salivary gland carcinoma treated with trastuzumab and a taxane, the therapy was well tolerated and resulted in five partial responses and a median progression-free survival of 10.8 months, indicating its efficacy.

One patient achieved a complete and durable remission, and trastuzumab showed greater activity than androgen deprivation therapy when both HER-2 and androgen receptors were co-expressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic HER-2-positive salivary gland carcinoma treated with trastuzumab and a taxane: a series of six patients. De Block, K., Vander Poorten, V., Dormaar, T., et al.[2017]

In a phase 2 trial involving 64 patients with metastatic salivary gland cancers, the combination of nivolumab and ipilimumab showed limited efficacy, with only 6% of patients with adenoid cystic carcinoma responding, while 16% of patients with other salivary gland cancers had objective responses.

The treatment was associated with significant safety concerns, as 38% of patients experienced severe adverse events, and the median progression-free survival was only 4.4 months for adenoid cystic carcinoma and 2.2 months for other types, indicating a need for more effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab plus ipilimumab in advanced salivary gland cancer: a phase 2 trial. Vos, JL., Burman, B., Jain, S., et al.[2023]

Surgery, guided by imaging techniques like MRI or CT scans, is the primary treatment for salivary gland tumors, with a focus on preserving the facial nerve and ensuring excision margins of at least 5 mm for malignant tumors.

Adjuvant therapies, including radiation and chemotherapy, are being explored for high-risk cases, with ongoing trials investigating the combination of cisplatin and radiation therapy, while targeted therapies are also under research to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of salivary gland tumors. Andry, G., Hamoir, M., Locati, LD., et al.[2022]

In a study of 287 patients with major salivary duct carcinoma, advanced age, larger tumor size (greater than 4 cm), and positive lymph nodes were identified as independent risk factors for poorer survival outcomes.

Postoperative radiotherapy significantly improved overall survival for patients with tumors larger than 4 cm, highlighting the potential benefit of adjuvant therapy in this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical value of adjuvant therapy on the prognosis of ductal carcinoma of the major salivary gland: a large-scale cohort study. Zhang, D., Li, L., Wen, T., et al.[2023]

Salivary gland carcinomas (SGC) have historically been difficult to treat with standard chemotherapy and immunotherapy, but recent discoveries of targetable molecular alterations have led to improved treatment outcomes.

Identified alterations such as HER2 upregulation and NTRK gene fusions are paving the way for precision therapies, with ongoing clinical trials exploring these new treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A molecular guide to systemic therapy in salivary gland carcinoma. Weaver, AN., Lakritz, S., Mandair, D., et al.[2023]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6101

Amivantamab for recurrent/metastatic adenoid cystic ... Amivantamab is a bispecific antibody that binds to the extracellular domains of EGFR and MET, causing immune-directed destruction of cancer cells.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05074940

NCT05074940 | Amivantamab in Adenoid Cystic Carcinoma The purpose of the study is to determine if treatment with amivantamab will be efficacious in patients with recurrent and metastatic adenoid cystic carcinoma.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10931369/

Translational Insights in the Landscape of Salivary Gland ... AdCC is characterized by a high capacity to locally recur and displays a poor prognosis with a survival rate of 24–45% at 5 years [13]. Lung ...

4. jnj.com jnj.com/media-center/press-releases/subcutaneous-amivantamab-delivers-promising-45-percent-overall-response-rate-with-median-duration-of-7-2-months-in-recurrent-or-metastatic-head-and-neck-cancer

Subcutaneous amivantamab delivers promising 45 percent ... Responses were rapid and durable, and tumor shrinkage was observed in 82 percent of patients New findings from this investigational study ...

5. spandidos-publications.com spandidos-publications.com/10.3892/ol.2025.14899

Oncology Letters According to data from the available literature, the response rate for CAP is estimated to be between 18 and 31% (47). In a phase II study ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761210s004lbl.pdf

highlights of prescribing information - accessdata.fda.gov The safety data described below reflect exposure to RYBREVANT at the recommended dosage in. 129 patients with locally advanced or metastatic NSCLC with EGFR ...

7. rybrevanthcp.com rybrevanthcp.com/

RYBREVANT® (amivantamab-vmjw) HCP The official healthcare provider website for RYBREVANT® (amivantamab-vmjw), a treatment for EGFR+ mNSCLC. See Full Prescribing & Safety Info.