Experimental infusion drug tested against recurrent nasopharyngeal cancer
NCT ID NCT07818486
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing an experimental drug called BL-M08D1 in adults with nasopharyngeal carcinoma that has come back or spread, as well as other solid tumors. Participants receive the drug by intravenous infusion every three weeks. The trial aims to find a safe dose for further study and to see whether tumors shrink in response to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BL-M08D1, an experimental drug given by intravenous infusion
- What this could lead to
- If it works, BL-M08D1 could offer another treatment option for people whose nasopharyngeal cancer has come back or spread, and researchers could study it in other solid tumors.
- What could go wrong
- This is an early-stage trial with about 30 participants, so it may not show clear benefit or may cause side effects that limit its use. Results in this small group may not apply to everyone.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- 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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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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. Voluntarily sign the informed consent form and agree to comply with the protocol requirements; 2. No gender restriction; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Recurrent or metastatic nasopharyngeal carcinoma and other solid tumors; 6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within 3 years; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose; 9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; 11. Organ function levels must meet the required criteria; 12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN); 13. Urine protein ≤1+ or ≤1000 mg/24h; 14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment and must be negative, and they must be non-lactating; all enrolled patients (both male and female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment; 15. The trial participant must be capable of and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol. Exclusion Criteria: 1. Use of chemotherapy, biotherapy, immunotherapy, or other systemic anti-cancer therapies within 4 weeks or 5 half-lives prior to the first dose; 2. History of severe cardiac or cerebrovascular disease; 3. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 4. Active autoimmune diseases and inflammatory diseases; 5. Diagnosis of another primary malignancy within 5 years prior to the first dose; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose; 7. Hypertension inadequately controlled by antihypertensive medications; 8. Poorly controlled blood glucose (diabetes); 9. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of Grade ≥2; 10. Severely impaired respiratory function; 11. Active central nervous system (CNS) metastases; 12. History of, or concurrent, central nervous system disorders; 13. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or hypersensitivity to any excipient component of BL-M08D1; 14. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 16. Active infection requiring systemic therapy within 4 weeks prior to the first dose of study drug; 17. Pleural, peritoneal, or pericardial effusion requiring drainage and/or associated with symptoms within 4 weeks prior to the first dose of study drug; 18. Imaging findings indicating that the tumor has invaded or encased major blood vessels (e.g., abdominal or thoracic vessels), the pericardium, or the heart; 19. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose; 20. Pregnant or breastfeeding women; 21. Other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in this clinical trial.
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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
2 sites. 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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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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