Can a Two-Drug attack shrink Hard-to-Treat head and neck tumors?
NCT ID NCT06437522
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This phase II trial is testing whether a combination of an experimental drug (BL-B01D1) and a PD-1 monoclonal antibody can shrink tumors in people with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal type) and other solid tumors. The study enrolls about 46 adults aged 18 to 75 whose cancer has returned or spread. Researchers are measuring how many patients respond to the treatment and how long the response lasts, while also monitoring safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of an experimental drug called BL-B01D1 and a PD-1 monoclonal antibody
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced head and neck cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the benefits are uncertain. The combination may cause significant side effects, and it may not work for everyone.
Why investors are watching
Sichuan Baili Pharmaceutical is testing its drug BL-B01D1 combined with a PD-1 antibody in 46 patients with recurrent or metastatic head and neck cancer and other solid tumors. For a small company, this phase II result matters because it will show whether the combination shrinks or controls tumors, which could determine the drug's future development and the company's value.
If it works: If the trial shows the combination controls the disease in a meaningful share of patients, the company could advance the drug to a larger study or attract a partner to fund further development.
If it fails: Phase II trials often fail to show enough benefit, and a negative or delayed result could set the program back and hurt the company's prospects. Investors should expect that failure is a common outcome at this stage.
AI-written from the trial record. Speculative, and not investment advice.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2024
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Subject volunteered to participate in the study and signed an informed consent; 2. Male or female aged ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG score 0-1; 5. Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors confirmed by histopathology and/or cytology; 6. Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Prior treatment with an ADC drug with TOP I inhibitors as a toxin; 2. Before the first delivery within four weeks or five half-life used anti-tumor treatment; Palliative radiotherapy was given within 2 weeks before the first dose; 3. Received any previous systemic antitumor regimen for solid tumors such as recurrent or metastatic head and neck squamous cell carcinoma; 4. Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis; 5. Use of an immunomodulatory drug within 14 days before the first dose of study drug; 6. Systemic corticosteroids were required within 2 weeks before the first dose of the study; 7. Has a history of severe disease of heart head blood-vessel; 8. Active autoimmune and inflammatory diseases; 9. Other malignant tumors that progressed or required treatment within 3 years before the first dose; 10. With ILD requiring steroid treatment, current ILD, or suspected ILD at screening; 11. Presence of: a) poorly controlled diabetes mellitus before study treatment; b) poorly controlled hypertension; c) history of hypertensive crisis or hypertensive encephalopathy; 12. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 13. Patients with active central nervous system metastasis; 14. Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage; 15. Had allergic history to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients; 16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 17. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection; 18. Active infection requiring systemic therapy; 19. Had participated in another clinical trial within 4 weeks before the first dose; 20. Who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders; 21. Other circumstances that the investigator deemed inappropriate for participation in the trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Head and neck squamous cell carcinoma are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NeoRTPC02): an open label, single-arm, phase II clinical trial
- Can a new drug shrink advanced solid tumors?
- Can steroid shots shield salivary glands from radiation damage?
- Can a new pill boost Immunotherapy's power against advanced tumors?
- Can heat make radiation more effective against head and neck cancer?
- Blood test may reveal hidden cancer cells in head and neck tumors