Can a Two-Drug attack shrink recurrent throat cancer?
NCT ID NCT07781358
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This phase II trial is testing whether combining becotatug vedotin with a PD-1 inhibitor can help people with recurrent nasopharyngeal carcinoma (a type of throat cancer). Participants will receive the drug combination for three cycles, then be evaluated for surgery. The goal is to see if this approach can shrink tumors, improve survival, and potentially make the cancer operable.
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 combined with a PD-1 inhibitor
- What this could lead to
- If successful, this combination could offer a new treatment option for recurrent nasopharyngeal carcinoma, potentially improving tumor shrinkage and survival rates.
- What could go wrong
- This is an early-phase, small study (25 participants). The combination may not work as hoped, and side effects from the drugs could be significant.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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: * Written informed consent obtained prior to any trial-related procedures. * ≥ 18 years of age. * Histologically or cytologically confirmed recurrent nasopharyngeal carcinoma (locoregional recurrence and/or regional lymph node recurrence), without distant metastases. Including patients with local recurrence at T2 stage and/or retropharyngeal lymph node metastasis adjacent to the internal carotid artery. * At least one lesion at baseline meeting RECIST 1.1 criteria for target lesions (TL). Tumor assessment must be performed by CT or MRI scan within 28 days before treatment. * ECOG performance status 0-1. * Life expectancy ≥ 3 months. * Adequate organ function for drugs and surgery * For female patients of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Cycle 1 Day 1) and the result must be negative. If the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy. * If there is a risk of conception, all subjects (male or female) must use contraceptive methods with a failure rate of \< 1% per year during the entire treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy, if applicable). Exclusion Criteria: * Diagnosis of any malignancy other than nasopharyngeal carcinoma within 5 years prior to first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been radically resected). * Prior treatment with an ADC drug containing MMAE as the payload. * Known active bleeding signs of the lesion under endoscopy. * Currently participating in an interventional clinical study, or having received another investigational drug or used an investigational device within 4 weeks prior to first dose. * Systemic treatment with traditional Chinese patent medicine with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin; excluding topical use for pleural effusion control) within 2 weeks prior to first dose. * Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment. * Receiving systemic glucocorticoid therapy (excluding intranasal, inhaled, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to first dose. Note: Physiological doses of glucocorticoids (≤ 10 mg/day prednisone or equivalent) are permitted. * History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. * Failure to fully recover from toxicity and/or complications caused by any prior intervention (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia) before starting treatment. * Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive). * Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy number exceeding the upper limit of normal of the central laboratory). Note: Hepatitis B subjects meeting the following criteria may also be enrolled: HBV viral load \< 1000 copies/mL (200 IU/mL) prior to first dose; subjects should receive anti-HBV therapy throughout the study chemotherapy period to prevent viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is needed. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection). * Receipt of live vaccine within 30 days prior to first dose (Cycle 1, Day 1). Note: Injectable inactivated influenza vaccines for seasonal flu are allowed within 30 days prior to first dose; however, intranasally administered live attenuated influenza vaccines are not permitted. * Pregnant or lactating women. Presence of any severe or uncontrolled systemic disease.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Eye and ENT Hospital of Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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