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

NCT ID: NCT07274852

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

The study is divided into two stages: the dose-escalation phase (Phase Ia) and the cohort-expansion phase (Phase Ib).

Conditions

Lung Cancer; Breast Cancer; Head and Neck Squamous Cell Carcinoma; Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lutetium [177Lu] BL-ARC001

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 6 weeks.

Interventions

Lutetium [177Lu] BL-ARC001

Administration by intravenous infusion for a cycle of 6 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. No gender restrictions;

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

4. Expected survival time ≥3 months;

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

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

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

8. ECOG performance status score of 0 or 1;

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

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

11. Organ function levels must meet the requirements;

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

13. Urine protein ≤2+ or ≤1000mg/24h;

14. 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.

Exclusion Criteria

1. Use of chemotherapy, biological therapy, or immunotherapy within 4 weeks or 5 half-lives prior to the first dose;

2. History of severe heart disease;

3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;

4. Active autoimmune or inflammatory diseases;

5. Diagnosis of other malignancies within 5 years prior to the first dose;

6. Hypertension poorly controlled by two antihypertensive medications;

7. History of interstitial lung disease (ILD) requiring hormonal therapy, current ILD, or ≥ Grade 2 radiation pneumonitis;

8. Symptoms of active central nervous system metastasis;

9. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of 177Lu-BL-ARC001;

10. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);

11. Cumulative dose of anthracyclines >360 mg/m² during prior (neo)adjuvant anthracycline therapy;

12. Positive human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;

13. Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;

14. Participation in another clinical trial within 4 weeks prior to the first dose;

15. Pregnant or lactating women;

16. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Rui Huang

Role: primary

Other Identifiers

177Lu-BL-ARC001-101

Identifier Type: -

Identifier Source: org_study_id