A Phase 2 interventional study of Becotatug Vedotin in Adenoid Cystic Carcinoma and Sinonasal Carcinoma, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Eye & ENT Hospital of Fudan University · Phase 2, Interventional, and Treatment
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Among 14 studies in Carcinoma, Adenoid Cystic with a site in China — 7 open to participants now, 7 under way, none of them phase 3. Carcinoma, Adenoid Cystic · China.
Among the 14 studies in Carcinoma, Adenoid Cystic with a site in China, this one is the 6th largest by planned enrollment of the 12 interventional ones that give a count, is one of 5 that started in 2026, is one of 10 in phase 2, and was the 11th registered.
86 studies on the registry are indexed under Carcinoma, Adenoid Cystic; 26 are open to participants now.
Browse Carcinoma, Adenoid Cystic studies →7 of the 14 studies in Carcinoma, Adenoid Cystic with a site in China are open now. Recruiting first, the newest first:
Eye & ENT Hospital of Fudan University · Sites in China
Ages 18–75
Eye & ENT Hospital of Fudan University · Sites in China
Ages 18–80
Eye & ENT Hospital of Fudan University · Sites in China
Ages 18–75
Eye & ENT Hospital of Fudan University · Sites in China
Ages 18–70
HitGen Inc. · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 23 Carcinoma, Adenoid Cystic studies recruiting now, 15 (65%) set no upper age limit and 3 (13%) stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is close to the median of 37 across 76 interventional studies indexed under Carcinoma, Adenoid Cystic.
Median enrollment 40 across the 12 interventional studies, 135 across the 2 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 14 have an industry lead sponsor. The 8 most frequent:
Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.
Eye & ENT Hospital of Fudan University has 5 studies filed under Carcinoma, Adenoid Cystic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Carcinoma, Adenoid Cystic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective, multicenter clinical study aims to evaluate the efficacy and safety of neoadjuvant therapy with MRG003 (Becotatug vedotin) combined with epirubicin in patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma (SNACC). The primary question is whether this combination can achieve a sufficient objective response rate (ORR) to enable subsequent radical surgery or improve disease control.
This is a prospective, multicenter, single-arm, open-label phase II clinical study. Patients with histologically confirmed recurrent sinonasal adenoid cystic carcinoma (SNACC) that is deemed unresectable by a multidisciplinary team (MDT) and positive for EGFR expression (IHC) are eligible.
Intervention:
Primary Outcome Measure: Objective response rate (ORR) according to RECIST v1.1, assessed 21 days (±7 days) after the third cycle.
Secondary Outcome Measures:
Sample Size: 40 evaluable patients. Assuming a historical ORR of 10% with single-agent epirubicin, the study is designed to detect an improvement to 35% with the combination (one-sided exact binomial test, α=0.05, power 80%). The sample size also ensures sufficient power for key secondary endpoints and supports the translational sub-study (≥28 successful organoid models).
Translational Research Component: Pre-treatment tumor biopsies will be used to establish patient-derived organoids (PDOs). Organoids will be characterized (H\&E, immunofluorescence, STR genotyping) and tested ex vivo for sensitivity to MRG003, epirubicin, and their combination. Associations between organoid drug sensitivity and clinical response (ORR, tumor shrinkage, PFS) will be explored.
Statistical Analysis: Primary analysis will be performed on the full analysis set (all treated patients). ORR and other binary endpoints will be reported with exact 95% confidence intervals (Clopper-Pearson method). PFS and OS will be estimated using Kaplan-Meier method. Translational data will be analyzed using Spearman rank correlation, Chi-square or Fisher's exact tests, and exploratory Cox regression.
Study Duration: Approximately 48 months, including 24 months enrollment, 3-6 months treatment/short-term follow-up per patient, and 24 months long-term survival follow-up after last patient enrollment.
Data Monitoring: An independent Data Safety Monitoring Board (DSMB) will conduct interim safety review after 20 patients are enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
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 in the skull base/sinonasal region according to v1.1 (longest diameter ≥ 10 mm).
(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 (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 disease requiring systemic therapy.
Symptomatic or urgent (e.g., requiring radiotherapy or surgery) central nervous system (CNS) .
Known severe 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive MRG003 (Becotatug vedotin) 2.0 mg/kg intravenously on day 1 plus epirubicin 75 mg/m² intravenously on day 1 of each 21-day cycle for 3 cycles.
Drug: Becotatug Vedotin
Becotatug vedotin (also known as MRG003) is an antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR). It consists of a recombinant anti-EGFR humanized monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a valine-citrulline linker. It is administered intravenously at 2.0 mg/kg on day 1 of each 21-day cycle for 3 cycles. Epirubicin is an anthracycline chemotherapeutic agent that inhibits topoisomerase II, thereby interfering with DNA replication and transcription. It is administered intravenously at 75 mg/m² on day 1 of each 21-day cycle for 3 cycles.
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1 criteria.
Time frame: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy (each cycle is 21 days).
Safety and tolerability
Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0.
Time frame: From first dose of study treatment up to 30 days after last dose (approximately 4 months per participant).
Surgical conversion rate
Proportion of participants who undergo radical surgery (R0 or R1 resection) after neoadjuvant therapy, as assessed by multidisciplinary team (MDT).
Time frame: Within 4 weeks after completion of neoadjuvant therapy (i.e., approximately 3.5 months from treatment start).
Disease control rate (DCR)
Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.
Time frame: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy.
R0 resection rate
Among participants who undergo surgery, proportion with negative microscopic margins (R0) on final histopathology.
Time frame: At time of surgery (within 4 weeks after neoadjuvant therapy completion).
Pathologic response rate
Among participants who undergo surgery, proportion achieving major pathologic response (≤10% viable tumor cells) or pathologic complete response (0% viable tumor cells).
Time frame: At time of surgery (within 4 weeks after neoadjuvant therapy completion).
Progression-free survival (PFS)
Time from enrollment to first documented disease progression (by RECIST v1.1) or death from any cause, whichever occurs first.
Time frame: Assessed every 3 months for the first 2 years, then every 6 months up to 5 years, or until death or study completion (up to 48 months from first participant enrolled).
Overall survival (OS)
Time from enrollment to death from any cause.
Time frame: Assessed every 3 months for the first 2 years, then every 6 months up to 5 years, or until death or study completion (up to 48 months from first participant enrolled).
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Oct 2028, 29 months after the start.
Of 28 phase 2 interventional studies under Carcinoma, Adenoid Cystic, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 67. This study's planned 29 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Becotatug vedotin
Eye & ENT Hospital of Fudan University →