Can a Two-Drug attack shrink tough lung cancers?

NCT ID NCT06437509

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase II trial is testing whether combining an experimental drug called BL-B01D1 with a PD-1 monoclonal antibody can shrink tumors in people with extensive-stage small cell lung cancer. The study enrolls 66 adults aged 18 to 75 who have newly diagnosed, advanced disease. Researchers are measuring how many patients respond to the treatment and how long they live without the cancer growing.

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 (izalontamab brengitecan) 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 small cell lung cancer, potentially improving tumor shrinkage and delaying disease progression.
What could go wrong
This is an early-phase trial with only 66 participants, so results may not apply broadly. The combination may cause significant side effects, and it is not yet known if it will improve survival.
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 patients with extensive-stage small cell lung cancer, a hard-to-treat disease. For a small company, this mid-stage readout on 66 participants could determine whether the combination shows enough benefit to advance, making the result a key value driver.

If it works: A positive result could show the combination controls the disease and has an acceptable safety profile, which might support further development and partnerships. That outcome would give the company a stronger position in a competitive lung cancer field.

If it fails: The trial could fail to show meaningful disease control or produce safety problems, which would likely end this program and hurt the company's prospects. Most phase II trials do not succeed, so failure is a real possibility.

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 66 people

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

Started

Jun 2024

Expected to finish

Dec 2027

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

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. Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology; 6. A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years; 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 use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors; 2. Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer; 3. Pathology suggested small cell carcinoma containing non-small cell carcinoma components; 4. Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ; 5. Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ; 6. QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ; 7. Active autoimmune diseases and inflammatory diseases ; 8. Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose; 9. Other malignancies that have progressed or require treatment within 5 years prior to the first dose; 10. Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at screening; 11. Prior to initiation of study treatment, there were: a) poorly controlled diabetes mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin levels of 8% or more; d) hypertension that is poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 12. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; Except for infusion set-related thrombosis; 13. Concurrent pulmonary disease leading to severe clinical impairment of respiratory function; 14. Patients with active central nervous system metastases; 15. Patients with large serosal effusions, or symptomatic serosal effusions, or poorly controlled serosal effusions; 16. History of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of the experimental drug; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 19. Severe infection within 4 weeks prior to first dose of study drug; Lung infection or active lung inflammation within 4 weeks; 20. Have participated in another clinical trial within 4 weeks prior to the first dose; 21. Have a history of psychotropic substance abuse and cannot be abstained from or have a history of severe neurological or psychiatric disorders; 22. Imaging examination showed that the tumor had invaded or encapsulated the large blood vessels in the chest; 23. Severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed policy; 24. Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed policy; 25. Subjects who are scheduled to receive or receive a live vaccine within 28 days prior to the first dose; 26. Other conditions that the investigator considers unsuitable to participate in this clinical trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Extensive stage small-cell lung cancer are added.

Our safety recommendation!

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.

  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

  • Shanghai East Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.