Actively Recruiting
A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-07
22
Participants Needed
1
Research Sites
106 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-label, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profile, 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 Gastrointestinal Tumors and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and agree to follow the study rules
- Any gender is eligible
- Aged 18 to 75 years for Phase Ia; 18 years and older for Phase Ib
- Expected to live at least 3 months
- Have locally advanced or metastatic solid tumors
- Agree to provide archived or fresh tumor tissue samples from the last 3 years
- Have at least one measurable tumor lesion by RECIST v1.1 criteria
- Have an ECOG performance status of 0 or 1
- Have recovered from previous cancer treatment side effects to Grade 1 or less
- No severe heart dysfunction and a left ventricular ejection fraction of 50% or higher
- Meet required organ function levels
- Have coagulation function with INR of 1.5 or less and activated partial thromboplastin time within 1.5 times the upper limit
- Have urine protein level of 2+ or less, or 1000 mg/24h or less
- Premenopausal women must have a negative pregnancy test within 7 days before treatment and must not be breastfeeding
- All participants must use effective contraception during treatment and for 6 months after treatment ends
You will not qualify if you...
- Received chemotherapy, biotherapy, or immunotherapy within 4 weeks or five half-lives before the first dose
- History of severe heart disease
- Have QT interval prolongation, complete left bundle branch block, or third-degree heart block
- Have active autoimmune or inflammatory diseases
- Diagnosed with another cancer within 5 years before the first dose
- Poorly controlled high blood pressure despite two medications
- History of interstitial lung disease needing steroids, current ILD, or grade 2 or higher radiation pneumonitis
- Symptoms of active brain metastases
- Allergy to recombinant humanized or chimeric antibodies or any ingredients of Lutetium [177Lu] BL-ARC001
- Previous organ or stem cell transplant
- Received more than 360 mg/m2 of anthracyclines in past cancer treatment
- Positive tests for HIV, active tuberculosis, or active hepatitis B or C infections
- Active infections needing systemic treatment
- Participated in another clinical trial within 4 weeks before the first dose
- Pregnant or breastfeeding women
- Any other condition the investigator considers unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sichuan Cancer Hospital
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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