Can a new drug combo keep advanced nasopharyngeal cancer at bay?
NCT ID NCT07783321
First seen Aug 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This phase III trial is testing whether adding an experimental drug called BL-B01D1 to standard maintenance therapy with a PD-1 antibody can help people with recurrent or metastatic nasopharyngeal carcinoma live longer without their cancer progressing. Participants first receive standard first-line treatment with a PD-1 antibody plus chemotherapy, then are randomly assigned to continue with the PD-1 antibody alone or with BL-B01D1 added. The study measures how long people go without disease progression and overall survival, aiming to see if the combination offers a better long-term outcome.
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) added to a PD-1 antibody as maintenance therapy
- What this could lead to
- If successful, this could offer a new maintenance option that delays cancer progression and improves survival for people with recurrent or metastatic nasopharyngeal carcinoma.
- What could go wrong
- This is an early-phase test in a specific cancer type, and adding a new drug may increase side effects without improving outcomes. Results are not yet known.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 414 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 2033
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 years and older
- 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. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Age ≥ 18 years; 3. Expected survival time ≥ 3 months; 4. Trial participants with nasopharyngeal carcinoma confirmed by histopathology and/or cytology, either initially diagnosed with metastatic disease or relapsed after curative-intent treatment; 5. Agree to provide tumor tissue samples obtained at or after the diagnosis of recurrent or metastatic disease; 6. Must have at least one measurable lesion as defined by RECIST v1.1; 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 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 starting treatment; serum pregnancy test must rule out pregnancy; they must not be breastfeeding and must use highly effective contraceptive methods throughout the entire treatment period and for 7 months after the last dose. For male trial participants whose partners are women of childbearing potential, adequate barrier contraception must be used throughout the entire treatment period and for 7 months after the end of treatment. Exclusion Criteria: 1. Trial participants who have received prior systemic therapy; 2. Those who have received prior therapy targeting the mechanism of tumor immuno-oncology; 3. Those who have previously received antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, or EGFR- and/or HER3-targeting antibodies/ADCs; 4. Trial participants who have received systemic immunostimulatory agents within 4 weeks prior to the first dose; 5. Those who have received radical radiotherapy, major surgery, or extensive-field radiotherapy within 4 weeks prior to study randomization; 6. History of severe cardiac or cerebrovascular disease; 7. Those receiving long-term systemic corticosteroid therapy (e.g., prednisone \>10 mg/day) prior to the first dose; 8. Active autoimmune diseases and inflammatory diseases; 9. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; 10. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 11. Diagnosis of active malignancy within 3 years prior to study randomization; 12. Hypertension inadequately controlled by two antihypertensive agents; 13. Trial participants with poorly controlled blood glucose; 14. History of interstitial lung disease (ILD) requiring steroid therapy, current ILD, or radiation pneumonitis of Grade ≥2; 15. Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function; 16. Active central nervous system (CNS) metastases; 17. Severe infection occurring within 4 weeks prior to study randomization; 18. Trial participants with massive serosal cavity effusion, symptomatic serosal cavity effusion, or poorly controlled serosal cavity effusion; 19. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, or cervical structures; 20. Severe, non-healing wounds, ulcers, or bone fractures within 4 weeks prior to signing informed consent; 21. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent; 22. Trial participants with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea; 23. Trial participants with a history of allergy to recombinant humanized antibodies or hypersensitivity to the investigational drug; 24. History of autologous or allogeneic stem cell transplantation; 25. Positive for human immunodeficiency virus (HIV) antibodies, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection; 26. History of severe neurological or psychiatric disorders; 27. Receipt of other unapproved investigational drugs or treatments within 4 weeks prior to study randomization; 28. Trial participants who plan to receive, or have received, live vaccines within 28 days prior to study randomization; 29. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial due to complications or other circumstances.
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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
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