Actively Recruiting
A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
26
Participants Needed
7
Research Sites
277 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
S
SystImmune Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1. In phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M07D1 in patients
CONDITIONS
Official Title
A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to follow study requirements
- Any gender
- Age 18 to 75 years for Phase Ia; 18 years and older for Phase Ib
- Expected survival of at least 3 months
- Confirmed inoperable locally advanced or metastatic HER2-positive/low-expression breast cancer or other solid tumors that have failed or are ineligible for standard therapy
- HER2 positive defined as IHC3+ or IHC2+ with ISH positive; HER2 low expression defined as IHC2+ with ISH negative or IHC1+
- Agree to provide archived or fresh tumor tissue samples within 2 years or be evaluated by investigator if unable
- At least one measurable lesion by RECIST V1.1
- ECOG performance status of 0 or 1
- Toxicity from prior therapy resolved to grade 1 or less (except some non-safety risks)
- No serious cardiac dysfunction; left ventricular ejection fraction ≥50%
- Adequate bone marrow, liver, renal, and coagulation function as defined
- Urinary protein ≤2+ or ≤1000mg/24h
- Negative pregnancy test for premenopausal women at risk and agreement to use effective contraception during treatment and 6 months after
You will not qualify if you...
- Prior chemotherapy, biotherapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy, or other antitumor therapies within specified washout periods before dosing
- Prior antibody-drug conjugate treatment with camptothecin toxins (Phase Ib only)
- History of severe heart disease such as symptomatic congestive heart failure grade 2 or higher, myocardial infarction, or unstable angina
- QT prolongation or serious heart conduction abnormalities
- Active autoimmune or inflammatory diseases except controlled hypothyroidism
- Other cancers diagnosed within 5 years except certain skin cancers
- Recent thrombotic events requiring treatment
- Poorly controlled pleural effusion or hypertension
- Severe lung diseases or history of interstitial lung disease
- Active central nervous system metastases unless stable for over 1 month
- Allergy to humanized or chimeric antibodies or BL-M07D1 components
- Prior organ or stem cell transplantation
- Excessive cumulative anthracycline dose
- Active infections including HIV, tuberculosis, hepatitis B or C
- Participation in another clinical trial within 4 weeks prior to dosing
- Pregnant or nursing women
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
Dongguan People's Hospital
Dongguan, Guangdong, China
Actively Recruiting
3
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangdong, Guangzhou, China, 510120
Actively Recruiting
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
5
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
6
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
7
Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 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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