New drug cocktail aims to fight Hard-to-Treat throat cancer
NCT ID NCT07381699
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests a combination of two drugs—Becotatug vedotin (a targeted therapy) and Pucotenlimab (an immunotherapy)—as a first treatment for people whose nasopharyngeal cancer has come back or spread. The study will enroll 30 adults and measure how long the cancer stays under control. The goal is to see if this combo works better than current options.
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 (a targeted drug) and Pucotenlimab (an immunotherapy drug)
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for people with advanced nasopharyngeal carcinoma, potentially slowing disease progression.
- What could go wrong
- This is an early Phase 2 trial with only 30 participants, so results may not apply broadly. The drugs can cause side effects like infusion reactions or immune-related issues, and the combination may not improve outcomes over existing therapies.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
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 75 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: 1. Aged 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place). 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Life expectancy ≥ 3 months. 4. Histologically or cytologically confirmed nasopharyngeal carcinoma (NPC). 5. Metastatic NPC (Stage IVB, AJCC 8th) or locally recurrent NPC unfit for curative local therapy (e.g., surgery, TACE, radiotherapy). 6. Must be treatment-naive for recurrent or metastatic NPC. 7. Must have ≥ 1 measurable lesions as defined per RECIST v1.1. 8. Adequate organ function. 9. For women of childbearing potential: negative pregnancy test within 7 days prior to treatment initiation. All participants of childbearing potential must agree to use effective contraception during the study and for 1 year after treatment discontinuation. 10. Willing and able to provide written informed consent and comply with study procedures and follow-up visits. Exclusion Criteria: 1. Peripheral neuropathy of Grade 2 or higher. 2. Anticipated need for any other local or systemic anti-tumor therapy during the study period. 3. Diagnosed and/or treated additional malignancy within 5 years of enrollment, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma. 4. Active central nervous system (CNS) metastases or carcinomatous meningitis. 5. Laboratory values within 7 days prior to enrollment falling outside specified eligibility ranges (e.g., Child-Pugh C; creatinine clearance \<30 mL/min; serum sodium \<135 mmol/L; serum potassium \<3.5 mmol/L). 6. Severe or uncontrolled cardiovascular disease. 7. History of or current interstitial lung disease, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, or symptomatic bronchospasm. 8. Active infection requiring systemic therapy. 9. Severe, or uncontrolled systematic diseases (e.g., uncontrolled hypertension, or uncontrolled diabetes). 10. Known history of testing positive for human immunodeficiency virus (HIV). 11. Known history of allogeneic hematopoietic stem cell, bone marrow, or solid organ transplantation. 12. Known active hepatitis B or C infection, or other severe liver disease. 13. Live vaccine within 30 days prior to the first dose. 14. Residual toxicity from prior anti-tumor therapy higher than grade 1 (except alopecia, fatigue, and grade 2 hypothyroidism). 15. Active autoimmune disease or a history of autoimmune disease requiring systemic steroid or immunosuppressive therapy. The following conditions are not exclusionary: mild asthma controlled with intermittent bronchodilators; stable hypothyroidism on hormone replacement; vitiligo; Graves' disease; or Hashimoto's disease. 16. Known history of Grade 3 or higher hypersensitivity to any component of MRG003 or to other monoclonal antibodies. 17. Uncontrolled pleural effusion, ascites, or pericardial effusion. 18. Pregnancy, breastfeeding, or unwillingness to use a highly effective method of contraception during the treatment period and for at least 180 days after the last dose. 19. Any other condition that, in the opinion of the investigator, may compromise the safety and integrity of the study participant.
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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 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.
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Other studies related to the condition(s) this trial covers.
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