Actively Recruiting
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
96
Participants Needed
6
Research Sites
302 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 gastrointestinal tumor and other 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 gastrointestinal tumor and other solid tumor will be evaluated.
CONDITIONS
Official Title
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign informed consent and follow study requirements.
- No gender restrictions.
- Age 18 to 75 years (Phase Ia); 18 years and older (Phase Ib).
- Expected survival time of 3 months or more.
- Diagnosed with locally advanced or metastatic triple-negative breast cancer or other solid tumors, failing or ineligible for standard therapy, and inoperable.
- Agree to provide archived or fresh tumor tissue samples within 3 years, or be evaluated by investigator if unable.
- At least one measurable lesion as defined by RECIST V1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Toxicity from prior antitumor therapy recovered to grade 1 or below, excluding certain asymptomatic lab abnormalities or non-safety risk toxicities.
- Adequate organ function including bone marrow, liver, and kidney parameters within specified limits.
- Coagulation function within specified limits (INR and APTT ≤1.5 times upper limit).
- Urinary protein levels ≤2+ or ≤1000 mg/24h.
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment start, not breastfeeding, and agree to use effective contraception during treatment and 6 months after.
You will not qualify if you...
- Anti-tumor therapies including chemotherapy, biological therapy, immunotherapy, radiotherapy, major surgery, targeted therapy within 4 weeks or 5 half-lives prior to first dose; mitomycin or nitrosoureas within 6 weeks; oral fluorouracil-like drugs or palliative radiotherapy within 2 weeks prior.
- Previous treatment with ADC drugs targeting TROP2 or using camptothecin derivatives.
- History of severe heart disease such as symptomatic congestive heart failure grade 2 or higher, NYHA grade 2 or higher heart failure, transmural myocardial infarction, or unstable angina.
- Prolonged QT interval (male QTc >450 msec or female QTc >470 msec), complete left bundle branch block, or third-degree atrioventricular block.
- Active autoimmune or inflammatory diseases requiring systemic treatment, except certain controlled conditions.
- Second primary tumor within 5 years before initial administration, except treated basal or squamous cell carcinoma or carcinoma in situ.
- Unstable thrombotic events requiring treatment within 6 months prior to screening, excluding infusion device-related thrombosis.
- Symptoms of active central nervous system metastasis; stable brain metastases allowed under defined conditions.
- Allergy to recombinant humanized or mouse chimeric antibodies or components of BL-B01D1.
- Previous organ or allogeneic hematopoietic stem cell transplantation.
- Cumulative anthracycline dose over 360 mg/m2 in prior adjuvant therapy.
- Positive HIV antibody, active tuberculosis, active hepatitis B or C infections.
- Active infections requiring systemic treatment such as severe pneumonia or septicemia.
- Participation in another clinical trial within 4 weeks prior to first dose.
- Other conditions deemed unsuitable by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
2
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
3
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
4
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
5
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
6
Zhejiang Cancer Hospital
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
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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