Actively Recruiting
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
570
Participants Needed
8
Research Sites
313 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-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 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-B01D1 in patients with locally advanced or metastatic solid tumor will be evaluated.
CONDITIONS
Official Title
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign informed consent and follow study procedures.
- No restriction on gender.
- Age 18 to 75 years for Phase Ia; age 18 years and older for Phase Ib.
- Expected survival time of at least 3 months.
- Confirmed diagnosis of locally advanced or metastatic solid tumor incurable or without standard treatment.
- Willingness to provide archived or fresh tumor tissue samples within 2 years, or evaluated by investigator if unable.
- At least one measurable lesion per RECIST v1.1.
- ECOG physical fitness score of 0 or 1.
- Previous antitumor therapy toxicities must have resolved to grade 1 or lower (with some exceptions).
- No serious cardiac dysfunction; left ventricular ejection fraction at least 50%.
- Adequate bone marrow, liver, kidney, and coagulation functions as defined by specific laboratory values.
- Urinary protein level no greater than 2+ or 1000 mg/24h.
- Negative pregnancy test and effective contraception for women of childbearing potential; contraceptive measures for all participants during and 6 months after treatment.
You will not qualify if you...
- Anti-tumor treatments such as chemotherapy, immunotherapy, radiotherapy, surgery, or targeted therapy within specified timeframes prior to first dose.
- History of severe heart diseases including congestive heart failure grade 2 or above, myocardial infarction, or unstable angina.
- Prolonged QT interval or certain heart conduction abnormalities.
- Active autoimmune or inflammatory diseases requiring systemic treatment.
- Other malignancies within 5 years except certain skin cancers treated by radical resection.
- Poorly controlled hypertension despite medication.
- Grade 3 lung disease or history of interstitial lung disease.
- Recent unstable thrombotic events within 6 months.
- Active central nervous system metastasis symptoms; stable brain metastases allowed under conditions.
- History of allergy to recombinant or chimeric antibodies or BL-B01D1 components.
- Prior organ or allogeneic stem cell transplantation.
- Excessive prior anthracycline exposure.
- Active infections including HIV, tuberculosis, hepatitis B or C.
- Active systemic infections requiring treatment.
- Participation in another clinical trial within 4 weeks before first dose.
- Other conditions deemed inappropriate for participation by investigators.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
3
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
4
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
5
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
7
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
8
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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