A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer

NCT ID: NCT06114511

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2026-04-30

Brief Summary

This phase Ib/II study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of injectable BL-M07D1 in patients with HER2-mutated, locally advanced or metastatic non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BL-M07D1

Participants receive BL-M07D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Group Type: EXPERIMENTAL

BL-M07D1

Intervention Type: DRUG

Administration by intravenous infusion

Interventions

BL-M07D1

Administration by intravenous infusion

Intervention Type: DRUG

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.

Exclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Zhang, PHD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

+8615013238943

Facility Contacts

Li Zhang

Role: primary

Other Identifiers

BL-M07D1-201

Identifier Type: -

Identifier Source: org_study_id