Actively Recruiting
A Phase Ib/II Trial Evaluating Safety and Effectiveness of BL-M07D1 in Women With HER2-expressing Recurrent or Metastatic Gynecologic Cancers
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
138
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of BL-M07D1, an investigational drug given by intravenous infusion, in women with HER2-expressing recurrent or metastatic gynecologic cancers. This phase Ib/II trial focuses on patients who have not responded to standard treatments or have no available standard treatment options. The study is designed as a single-arm, open-label, multicenter trial to assess how well the drug works and its safety profile. Participants receive BL-M07D1 through an intravenous infusion during the first 3-week cycle. If the patient shows clinical benefit, they may continue to receive additional cycles of treatment. Treatment will stop if the disease progresses, if side effects become intolerable, or for other reasons determined by the study team. Throughout the study, researchers will monitor patients for up to approximately 24 months to evaluate outcomes such as the recommended dose for phase II, response rates, disease control, duration of response, and progression-free survival. Safety assessments include tracking adverse events and measuring drug levels and immune responses. Participants will provide tumor tissue samples and undergo regular evaluations to support these measurements and ensure ongoing monitoring of their health during the trial.
CONDITIONS
Brief 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...
- Signed informed consent and agreement to follow protocol
- Female gender
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Recurrent or metastatic HER2-positive or low-expression gynecologic malignancies with failure or intolerance to standard treatment or no standard treatment available
- Histopathology confirming HER2 positive or low expression
- Consent to provide archived or fresh tumor tissue samples within 2 years
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Toxicity from previous antitumor therapy returned to grade 1 or less per NCI-CTCAE v5.0
- No severe cardiac dysfunction with left ventricular ejection fraction of 50% or higher
- No recent blood transfusion or use of growth factors within 14 days before screening
- Urinary protein level of 2+ or less or less than 1000 mg/24h
- Albumin level of 30 g/L or higher
- Negative pregnancy test within 7 days before treatment for women likely to give birth, and non-lactating with adequate contraception during treatment and for 6 months after
You will not qualify if you...
- Received prior anti-tumor therapy before first dose including mitomycin, nitrosoureas, oral fluorouracils, palliative radiotherapy, or anti-tumor traditional Chinese medicine
- Prior ADC drug therapy with camptothecin derivative toxins
- History of serious cardiovascular or cerebrovascular diseases
- Active autoimmune or inflammatory diseases
- Other malignant tumors within 5 years except certain cured skin, bladder, prostate, cervix, or breast cancers
- Unstable thrombotic events within 6 months before screening
- Massive, symptomatic, or poorly controlled effusions
- Poorly controlled hypertension (systolic >150 mmHg or diastolic >100 mmHg)
- Current interstitial lung disease or related conditions requiring steroid therapy
- Central nervous system metastases or carcinomatous meningitis
- Allergy to recombinant humanized or human-mouse chimeric antibodies or BL-M07D1 ingredients
- Previous organ or allogeneic hematopoietic stem cell transplantation
- HIV antibody positive or active tuberculosis, hepatitis B, or hepatitis C infections
- Active infections requiring systemic therapy
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or lactating women
- Investigator judgment against participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive BL-M07D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. Treatment continues until disease progression, intolerable toxicity, or other reasons.
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
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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