Actively Recruiting
A Study of Lutetium [177Lu]-BL-ARC001 in Patients With Locally Advanced or Metastatic Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-06
22
Participants Needed
1
Research Sites
103 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 cohort-expansion non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of Lutetium \[177Lu\] BL-ARC001 in patients with locally advanced or metastatic solid tumors.
CONDITIONS
Official Title
A Study of Lutetium [177Lu]-BL-ARC001 in Patients With Locally Advanced or Metastatic Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow study rules
- No gender restrictions
- Age 18 to 75 years for Phase Ia; 18 years and older for Phase Ib
- Expected survival of at least 3 months
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors unresponsive to standard treatment
- Agree to provide archived or fresh tumor tissue samples from the past 3 years
- Have at least one measurable tumor lesion by RECIST v1.1
- ECOG performance status of 0 or 1
- Side effects from prior antitumor therapy recovered to Grade 1 or less per NCI-CTCAE v5.0
- No severe heart dysfunction with left ventricular ejection fraction 50% or higher
- Meet required organ function levels
- Coagulation function: INR ≤1.5 and APTT ≤1.5 times upper limit of normal
- Urine protein level ≤2+ or ≤1000 mg/24h
- Premenopausal women with childbearing potential must have a negative pregnancy test within 7 days before treatment and not be breastfeeding
- All participants must use effective barrier contraception during treatment and for 6 months after treatment ends
You will not qualify if you...
- Received chemotherapy, biological therapy, or immunotherapy within 4 weeks or 5 half-lives before first dose
- History of severe heart disease
- Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Diagnosis of other cancers within 5 years prior to first dose
- Poorly controlled hypertension despite two antihypertensive medications
- History or current interstitial lung disease requiring hormonal therapy or Grade 2 or higher radiation pneumonitis
- Symptoms of active central nervous system metastasis
- Allergy to recombinant humanized antibodies, human-mouse chimeric antibodies, or any excipient in Lutetium [177Lu]-BL-ARC001
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation
- Cumulative anthracycline dose over 360 mg/m² during previous treatments
- Positive HIV antibody or active tuberculosis, hepatitis B, or hepatitis C infections
- Active infection requiring systemic treatment such as severe pneumonia or sepsis
- Participation in another clinical trial within 4 weeks prior to first dose
- Pregnant or lactating women
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, 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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