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New drug duo aims to shrink tough cancers

NCT ID NCT06475300

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests a new drug called BL-B01D1 combined with an immunotherapy (PD-1 antibody) in people with advanced lung cancer, nasopharyngeal cancer, or other solid tumors that have spread. The goal is to see if the combination can shrink tumors and control the disease. About 570 adults will take part, and the trial is currently recruiting.

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 (a drug) combined with a PD-1 monoclonal antibody (an immunotherapy)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced lung cancer, nasopharyngeal cancer, or other solid tumors.
What could go wrong
This is an early-phase trial (Phase 2) with no results yet. The combination may not work better than existing treatments, and side effects from the drugs could be serious.
Why investors are watching

Sichuan Baili Pharmaceutical is running a phase II trial of its drug BL-B01D1 combined with a PD-1 antibody in 570 patients with advanced lung cancer, nasopharyngeal cancer, and other solid tumors. For a small company, this readout tests whether its lead drug works in a broad set of common cancers, which could define the company's value.

If it works: A positive result could show that BL-B01D1 helps control disease in multiple tumor types, potentially supporting further development and partnerships. That outcome would matter because the company has few other products in late-stage testing.

If it fails: Phase II trials often fail to show enough benefit, and a negative or delayed result could set back the drug's development and hurt the company's prospects. Investors should expect that the trial may not succeed.

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 570 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Dec 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 years and older

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Sign the informed consent form voluntarily and follow the protocol requirements; 2. Any gender; 3. Age: ≥18 years old; 4. Expected survival time for 3 months or more; 5. Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology; 6. Subjects were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. ECOG 0 or 1; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. No serious cardiac dysfunction, left ventricular ejection fraction 50% or higher; 11. screening period not allowed within 14 days before a blood transfusion, are not allowed to use any cell growth factor, and/or liters of platelet medicine, organ function level must conform to the requirements; 12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN; 13. The urine protein + 2 or 1000 mg / 24 h or less or less; 14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy; 2. In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion; 3. Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Fluorouracil class oral drugs, etc.; 4. Serious heart disease; 5. Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia; 6. Active autoimmune and inflammatory diseases; 7. Before the first delivery within 5 years diagnosed as other malignant tumor; 8. Two antihypertensive drugs poorly controlled hypertension; 9. Patients with poor glycemic control; 10. With a history of ILD, current ILD or suspected suffering from such diseases during screening; 11. Complicated with pulmonary diseases leading to severe respiratory function impairment; 12. There is a lot of serous cavity effusion, or have a serous cavity effusion and has symptoms, or poorly controlled serous cavity effusion patients; 13. Imaging studies suggest tumor has violated or package around the chest, neck, pharyngeal large blood vessels; 14. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded; 15. Active central nervous system of patients; 16. For restructuring or human mouse chimeric antibody on study of humanized anti-platelet antibody has a history of allergies or allergic to BL - B01D1 any supplementary material composition of patients; 17. Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT); 18. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection; 19. Active infection requiring systemic therapy; 20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 21. Had participated in another clinical trial within 4 weeks before the first dose; 22. Other conditions for trial participation were not considered appropriate by the investigator.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

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