A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

NCT ID: NCT07232407

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-14
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

The study is divided into two phases: a dose escalation phase (Phase Ia) and a cohort expansion phase (Phase Ib).

Conditions

Gastrointestinal Tumors; 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. Gender: no restriction;

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

4. Expected survival time ≥3 months;

5. Locally advanced or metastatic solid tumors;

6. Agree 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 meeting the RECIST v1.1 criteria;

8. ECOG performance status score of 0 or 1;

9. Toxicities from prior antitumor therapy have 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 ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;

13. Urine protein ≤2+ or ≤1000mg/24h;

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

Exclusion Criteria

1. Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose;

2. History of severe heart disease;

3. QT interval prolongation, 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 steroid treatment, current ILD, or ≥ Grade 2 radiation pneumonitis;

8. Symptoms of active central nervous system metastases;

9. History of allergy to recombinant humanized or chimeric antibodies, or allergy to any excipient of Lutetium [177Lu] BL-ARC001;

10. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;

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

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

13. Active infection requiring systemic treatment;

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

15. Pregnant or lactating women;

16. Any other condition 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

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Tongyu Lin

Role: primary

Other Identifiers

177Lu-BL-ARC001-102

Identifier Type: -

Identifier Source: org_study_id