New drug duo aims to make inoperable sinus cancer removable
NCT ID NCT07522879
First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times
Summary
This phase 2 trial tests a combination of two drugs—becotatug vedotin (a targeted antibody-drug conjugate) and epirubicin (a standard chemo)—in 40 people with EGFR-positive, recurrent sinonasal adenoid cystic carcinoma that cannot be surgically removed. The goal is to shrink the tumor enough to allow radical surgery. The study measures how many patients respond and whether they can then undergo successful tumor removal.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Becotatug vedotin (MRG003) combined with epirubicin
- What this could lead to
- If successful, this combination could shrink tumors enough to allow surgical removal, potentially improving disease control and survival for a rare cancer with few options.
- What could go wrong
- This is a small, early-phase trial (40 people) with no control group. The drugs may cause side effects like nerve damage or heart toxicity, and the response rate may be too low to enable surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Jul 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Age ≥ 18 years, male or female. Histopathologically confirmed sinonasal adenoid cystic carcinoma (SNACC) with measurable recurrent disease located in the sinonasal/skull base region, irrespective of the presence of regional lymph node or distant metastases. EGFR expression positive by immunohistochemistry (IHC) performed at a central laboratory. Multidisciplinary team (MDT) assessment at baseline confirms that the tumor is not amenable to radical (R0) surgical resection. At least one measurable lesion in the skull base/sinonasal region according to RECIST v1.1 (longest diameter ≥ 10 mm). Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate bone marrow, hepatic, renal, and cardiac function as defined by protocol-specified laboratory parameters. Willing to provide written informed consent (including consent for clinical treatment and biospecimen research) and able to comply with study procedures. Exclusion Criteria: Prior treatment with any antibody-drug conjugate (ADC) that contains monomethyl auristatin E (MMAE) as the payload. Prior systemic chemotherapy containing epirubicin or any other anthracycline within 6 months before study enrollment. Active uncontrolled infection, or active autoimmune disease requiring systemic therapy. Symptomatic or urgent (e.g., requiring radiotherapy or surgery) central nervous system (CNS) metastases. Known severe hypersensitivity to any component of the study drugs. Pregnant or breastfeeding women, or men/women planning to become pregnant within 6 months after the last dose of study treatment. Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study participation, increase patient risk, or confound data interpretation.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adenoid cystic carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Eye & ENT Hospital of Fudan University
RECRUITINGShanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a new drug combo shrink Hard-to-Treat salivary gland tumors?
- Can a targeted drug shrink rare salivary gland tumors?
- Experimental drug tazemetostat offered to patients with rare, aggressive tumors
- New drug cocktail targets genetic weakness in rare cancer
- Drug duo takes on rare head and neck tumors