Can a new drug combo shrink High-Risk throat tumors?
NCT ID NCT07797881
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This phase II trial tests whether the experimental drug BL-B01D1, given with or without a PD-1 antibody, can improve tumor shrinkage in people with high-risk locally advanced nasopharyngeal carcinoma, a type of throat cancer. Participants also receive standard chemotherapy drugs gemcitabine and cisplatin. The study measures how many patients achieve a complete response after induction therapy, and also tracks survival and cancer spread over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BL-B01D1 (izalontamab brengitecan) with or without a PD-1 monoclonal antibody, plus standard chemotherapy (gemcitabine and cisplatin)
- What this could lead to
- If it works, this could lead to a new treatment option that shrinks tumors more effectively before standard therapy, potentially improving long-term control of high-risk nasopharyngeal carcinoma.
- What could go wrong
- This is a phase II trial with only 60 participants, so results may not hold up in larger studies. The drug combination may cause side effects, and it is not yet known if it will improve survival or cure the disease.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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. No gender restriction; 2. Age: ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. Pathologically confirmed as newly diagnosed nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)"; 5. Patients with locally regionally advanced nasopharyngeal carcinoma; 6. Must have at least one measurable lesion as defined by RECIST v1.1; 7. Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 1 year, or fresh tissue samples; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 9. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; 10. Organ function levels must meet the required criteria; 11. Urine protein ≤1+ or ≤1000 mg/24h; 12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment; serum pregnancy test must exclude pregnancy, and patients must be non-lactating; all enrolled trial participants (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the completion of treatment. Exclusion Criteria: 1. Prior receipt of any anti-tumor systemic therapy regimen for nasopharyngeal carcinoma; 2. Use of modern traditional Chinese medicine preparations that have been approved by the NMPA for anti-tumor therapy within 2 weeks prior to the first dose; 3. History of severe cardiac or cerebrovascular disease; 4. Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 5. Active autoimmune diseases and inflammatory diseases; 6. Diagnosis of active malignancy within 3 years prior to study randomization; 7. Hypertension inadequately controlled by two antihypertensive agents; 8. Trial participants with poorly controlled blood glucose; 9. History of interstitial lung disease/interstitial pneumonia requiring corticosteroid therapy, etc.; 10. Concurrent pulmonary disease resulting in severe impairment of respiratory function; 11. Trial participants with massive serous cavity effusion, or symptomatic serous cavity effusion, or serous cavity effusion that is poorly controlled; 12. Imaging findings indicating tumor invasion or encasement of major blood vessels in the neck, pharynx, or other regions; 13. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; 14. Trial participants with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-B01D1; 15. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation; 16. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 17. Severe infection occurring within 4 weeks prior to the first use of the investigational drug; 18. History of psychotropic substance abuse that cannot be abstained from, or history of severe neurological or psychiatric disorders; 19. Severe and unhealed wounds, ulcers, or fractures within 4 weeks prior to signing informed consent; 20. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first dose of the investigational drug; 21. Trial participants with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.; 22. Trial participants who plan to receive or have received live vaccines within 28 days prior to study randomization; 23. Other conditions that, in the investigator's judgment, make the participant unsuitable for participation in this clinical trial due to complications or other reasons.
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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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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could avoiding Pre-Radiation tooth removal protect jaw health?