RecruitingPhase 1NCT07274852

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

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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

22 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new radioactive drug called 177Lu-BL-ARC001 in people with advanced lung cancer, breast cancer, head and neck cancer, or other solid tumors that have already stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older (up to 75 for the early phase) - You have an advanced or metastatic solid tumor that has not responded to standard treatment - Your tumor is measurable on a scan - You are generally in good physical condition (ECOG 0 or 1) - Your heart, kidneys, liver, and blood counts are within acceptable ranges - You are willing to use contraception during and for 6 months after treatment **You may NOT be eligible if...** - You received chemotherapy or immunotherapy within the past 4–5 weeks - You have a serious heart condition or irregular heartbeat - You have active autoimmune disease - You have another cancer diagnosed in the past 5 years - You have active HIV, hepatitis B, hepatitis C, or tuberculosis - You are pregnant or breastfeeding - You have had an organ or stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLutetium [177Lu] BL-ARC001

Administration by intravenous infusion for a cycle of 6 weeks.


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT07274852


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