Actively Recruiting
A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
138
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-arm, open, multicenter, non-randomized phase Ib/II clinical study evaluating the efficacy and safety of BL-M07D1 for injection in patients with HER2-expressing recurrent or metastatic gynecologic malignancies.
CONDITIONS
Official Title
A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide voluntary informed consent and follow study rules
- Female gender
- Age between 18 and 75 years
- Expected survival of at least 3 months
- Recurrent or metastatic HER2-positive or low-expression gynecologic cancers after failure or intolerance of standard treatment or no standard treatment available
- Histopathology confirming HER2 positive or low expression
- Agree to provide archived or fresh tumor tissue samples within 2 years
- At least one measurable tumor lesion per RECIST v1.1
- ECOG performance status score of 0 or 1
- Previous treatment toxicities resolved to grade 1 or less according to NCI-CTCAE v5.0
- No severe heart dysfunction; left ventricular ejection fraction 50% or higher
- No blood transfusions or growth factor/platelet drug use within 14 days before screening, with acceptable organ function
- Urinary protein level 2+ or less, or 1000 mg/24h or less
- Albumin level 30 g/L or higher
- Negative pregnancy test within 7 days before treatment and not breastfeeding; agree to use contraception during treatment and for 6 months after
You will not qualify if you...
- Prior anti-tumor therapy including Mitomycin, nitrosoureas, oral fluorouracils, palliative radiotherapy, or anti-tumor traditional Chinese medicine
- Previous antibody-drug conjugate therapy with camptothecin derivative toxin
- History of serious cardiovascular or cerebrovascular diseases
- Active autoimmune or inflammatory diseases
- Other cancers within 5 years except certain cured skin, bladder, prostate, cervix, or breast cancers
- Unstable blood clots requiring treatment within 6 months before screening
- Large or symptomatic fluid buildup or poorly controlled effusions
- Poorly controlled high blood pressure (systolic >150 mmHg or diastolic >100 mmHg)
- Current or past interstitial lung disease, drug-induced pneumonia, or radiation pneumonitis requiring steroids
- Central nervous system metastases or carcinomatous meningitis
- History of allergy to recombinant humanized or human-mouse chimeric antibodies or BL-M07D1 ingredients
- Previous organ or stem cell transplantation
- Positive for HIV antibodies or active tuberculosis, hepatitis B or C infections
- Active infections requiring systemic treatment like severe pneumonia or sepsis
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or breastfeeding women
- Investigator's decision deeming unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 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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