Actively Recruiting
A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-08-03
98
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow study rules
- Any gender
- Age between 18 and 75 years old
- Expected survival time of at least 3 months
- Histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer
- Confirmed HER2-sensitive mutations by previous testing or trial lab
- Advanced stage patients who received platinum-based chemotherapy and immunotherapy and cannot tolerate standard treatment or have disease progression
- Consent to provide archived or fresh tumor tissue samples within 2 years for biomarker testing, or evaluated by investigators if unable
- At least one measurable lesion per RECIST v1.1
- ECOG performance status of 0 or 1
- Toxicity from previous cancer therapy resolved to grade 1 or less
- No severe cardiac dysfunction, left ventricular ejection fraction 50% or higher
- Organ function meets study requirements
- Coagulation function: INR ≤1.5 and APTT ≤1.5 times upper limit
- Urine protein ≤2+ or ≤1000 mg/24h
- Premenopausal women must have negative pregnancy test within 7 days before treatment and not be breastfeeding
- All patients advised to use adequate barrier contraception during treatment and for 6 months after
You will not qualify if you...
- Received chemotherapy, biological therapy, immunotherapy, or other cancer treatments within 4 weeks or 5 half-lives before first dose (6 weeks for some drugs)
- Prior treatment with ADC drugs containing camptothecin derivatives
- Presence of other gene mutations for targeted therapy
- History of severe cardiovascular or cerebrovascular diseases
- Active autoimmune or inflammatory diseases
- Other cancers within 5 years before first dose
- Unstable thrombosis or embolism requiring treatment within 6 months
- Poorly controlled or symptomatic fluid accumulation like pericardial, pleural, peritoneal, or pelvic effusions
- Poorly controlled hypertension (systolic >150 mmHg or diastolic >100 mmHg)
- Current or past interstitial lung disease or radiation pneumonitis needing steroids
- Central nervous system metastases or carcinomatous meningitis
- Allergy to recombinant humanized or human-mouse chimeric antibodies or BL-M07D1 ingredients
- Prior organ or allogeneic stem cell transplantation
- Positive HIV antibody, active tuberculosis, active hepatitis B or C infection
- Active infections needing systemic therapy
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or lactating women
- Other conditions judged by investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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