A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Lutetium [177Lu]-BL-ARC001 Injection in Patients With Locally Advanced or Metastatic Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Voluntarily sign the informed consent form and comply with the protocol requirements;

• No gender restrictions;

• Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);

• Expected survival time ≥3 months;

• Histologically or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment;

• Agreement to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 3 years;

• Must have at least one measurable lesion as defined by RECIST v1.1;

• ECOG performance status score of 0 or 1;

• Toxicity from prior antitumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;

⁃ No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

⁃ Organ function levels must meet the requirements;

⁃ Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;

⁃ Urine protein ≤2+ or ≤1000mg/24h;

⁃ For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative. Patients must not be breastfeeding; all enrolled patients (regardless of gender) should adopt adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.

Locations
Other Locations
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 22
Treatments
Experimental: Lutetium [177Lu] BL-ARC001
Participants receive Lutetium \[177Lu\] BL-ARC001 for the first cycle (6 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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