Evaluating BL-M07D1 for HER2-mutated lung cancer

A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2 Mutated, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

This study is testing a new injectable drug called BL-M07D1 to see if it can help people with HER2-mutated lung cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06114511 on ClinicalTrials.gov

What this trial studies

This phase Ib/II study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of the injectable drug BL-M07D1 in patients diagnosed with HER2-mutated, locally advanced or metastatic non-small cell lung cancer. Participants will be closely monitored for their response to the treatment, and the study will involve collecting tumor samples for biomarker testing. The trial is designed for patients who have previously undergone platinum-based chemotherapy and immunotherapy but have not achieved satisfactory results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable locally advanced or metastatic non-small cell lung cancer and confirmed HER2-sensitive mutations.

Not a fit: Patients with non-HER2-mutated lung cancer or those who have not previously received standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-mutated non-small cell lung cancer.

How similar studies have performed: Other studies targeting HER2 mutations in lung cancer have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Li Zhang, PHD — Sun Yat-sen University
• Study coordinator: Sa Xiao, PHD

Conditions Non-small Cell Lung Cancer