Actively Recruiting
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-21
20
Participants Needed
2
Research Sites
101 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 an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in patients with locally advanced or metastatic HER2 positive/negative breast cancer and other solid tumors.
CONDITIONS
Official Title
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agree to follow the study protocol
- Any gender
- Aged 18 to 75 years for Phase Ia; 18 years or older for Phase Ib
- Expected survival time of at least 3 months
- Diagnosed with locally advanced or metastatic HER2 positive or negative breast cancer or other solid tumors
- Willing to provide archival or fresh tumor tissue samples within 3 years
- Have at least one measurable extracranial lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Toxicity from previous cancer treatments resolved to grade 1 or less
- No severe cardiac dysfunction; left ventricular ejection fraction at least 50%
- No blood transfusion within 14 days before first study drug dose; organ function meets requirements
- Coagulation function with INR of 1.5 or less and APTT of 1.5 times upper limit of normal or less
- Premenopausal women must have a negative pregnancy test within 7 days before treatment and not be lactating
- All participants advised to use barrier contraception during treatment and for 6 months after
You will not qualify if you...
- Recent chemotherapy, biological therapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks; oral fluorouracil
- History of severe heart disease
- Prolonged QT interval or severe arrhythmias
- Active autoimmune or inflammatory diseases
- Other cancers diagnosed within 5 years before first dose
- Unstable thrombotic events needing treatment within 6 months
- Poorly controlled hypertension despite two medications
- History or current interstitial lung disease or radiation pneumonitis grade 1 or higher
- Poor blood sugar control
- Pulmonary diseases causing severe breathing problems
- Primary CNS tumors or CNS metastases after failed local treatment
- Allergy to humanized or chimeric antibodies or to BL-M17D1 components
- Prior organ or stem cell transplantation
- Prior anthracycline therapy exceeding protocol dose limits
- Positive for HIV, active tuberculosis, or active hepatitis B or C
- Active serious infections within 4 weeks or pulmonary infections within 2 weeks
- Large or symptomatic fluid buildup not controlled
- Participation in another trial within 4 weeks
- Pregnant or breastfeeding women
- Superior vena cava syndrome requiring no rehydration
- Severe neurological or psychiatric illness
- Severe wounds, ulcers, or fractures within 4 weeks
- Significant bleeding or bleeding tendency within 4 weeks
- History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Scheduled to receive or received live vaccine within 28 days
- Investigator judgment deeming participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 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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