Can a targeted drug hit the mark against HER2-mutated lung cancer?

NCT ID NCT06114511

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 3 times

Summary

This trial is testing an experimental drug called BL-M07D1 in people with a specific type of advanced non-small cell lung cancer that has a HER2 mutation. The study aims to find the best dose and see how well the drug shrinks tumors, while also checking for side effects. Participants receive the drug through an IV infusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental antibody-drug conjugate called BL-M07D1
What this could lead to
If successful, this could provide a new targeted treatment option for people with HER2-mutated non-small cell lung cancer.
What could go wrong
This is an early-phase trial, so the drug may not prove effective or could cause significant side effects. Results may not apply to all patients.
Why investors are watching

Sichuan Baili Pharmaceutical is testing BL-M07D1, an injectable drug, in patients with a specific type of lung cancer that has a HER2 mutation and has spread or cannot be removed by surgery. This small company's value depends heavily on this drug's success, so the safety and effectiveness results from this 78-patient trial will be a major signal for the company's future.

If it works: If the trial shows the drug is safe and controls the disease, it could support further development and eventual approval, giving the company a potential product in a targeted cancer treatment area. A positive readout could also strengthen the company's position with partners or investors.

If it fails: The trial could fail to show enough benefit or reveal safety problems, which would likely set back the drug's development and hurt the company's prospects. Trials in cancer often fail, so a negative result 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

78 people

The number who actually took part.

Started

Apr 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. Voluntarily sign the informed consent and follow the requirements of the protocol. 2. No gender limit. 3. Age: ≥18 years old and ≤75 years old. 4. expected survival time ≥3 months. 5. Histologically or cytologically confirmed, unresectable locally advanced or metastatic non-small cell lung cancer. 6. Confirmed known HER2-sensitive mutations, investigator-confirmed previous testing results, and trial site laboratory testing results were acceptable. 7. Patients in the advanced stage who had received platinum-based chemotherapy and immunotherapy concurrent or sequential therapy were unable to tolerate standard treatment or had disease progression during or after treatment. 8. Consent to provide archived tumor tissue or fresh tissue samples from primary or metastatic sites within 2 years for biomarker testing; Participants who were unable to provide tumor tissue samples could be enrolled if they met other inclusion and exclusion criteria after evaluation by investigators. 9. Must have at least one measurable lesion according to RECIST v1.1 definition. 10. ECOG score 0 or 1. 11. Toxicity of previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 . 12. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%. 13. Organ function levels must meet the requirements. 14. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN. 15. Urine protein ≤2+ or ≤1000mg/24h. 16. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, serum/urine pregnancy must be negative, 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. Received chemotherapy, biological therapy, immunotherapy or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.). 2. Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin. 3. Presence of other gene mutations for targeted drug therapy. 4. A history of severe cardiovascular and cerebrovascular diseases. 5. Active autoimmune or inflammatory diseases. 6. Patients with other malignant tumors within 5 years before the first administration. 7. Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; Infusion-related thrombosis was excluded. 8. Patients with poorly controlled pericardial effusion, pleural effusion, peritoneal effusion, or pelvic effusion with clinical symptoms were judged by the investigator to be ineligible for enrollment. 9. Hypertension poorly controlled by antihypertensive drugs (systolic BP \> 150 mmHg or diastolic blood pressure \> 100 mmHg). 10. Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases. 11. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases). . 12. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-M07D1. 13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT). 14. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number \> lower detection limit) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA \> lower detection limit). 15. Active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc. 16. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose). 17. Pregnant or lactating women. 18. Other circumstances considered by the investigator to be inappropriate for participation in the 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.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

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