Lutetium [177Lu]-BL-ARC001 for advanced lung, breast, head and neck 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

This study will test a radiolabeled drug called Lutetium [177Lu]-BL-ARC001 in adults with advanced or metastatic solid tumors (such as lung, breast, or head and neck cancers) whose standard treatments have not worked.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07274852 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter phase I trial uses a dose-escalation (Phase Ia) design followed by cohort expansion (Phase Ib) to study Lutetium [177Lu]-BL-ARC001 in people with locally advanced or metastatic solid tumors. The primary goals are to determine safety, tolerability, and pharmacokinetics, with secondary aims to collect preliminary signs of antitumor activity. Eligible adults must have histologically confirmed disease with at least one measurable lesion, ECOG performance status 0–1, adequate organ and coagulation function, and provide recent tumor tissue. Participants receive escalating doses of the radiolabeled agent at specialized centers and are closely monitored with labs, imaging, and adverse event assessments.

Who should consider this trial

Good fit: Ideal candidates are adults with locally advanced or metastatic solid tumors (including lung, breast, or head and neck cancers) who have measurable disease, ECOG 0–1, adequate organ and cardiac function, and whose prior standard treatments have failed.

Not a fit: Patients with poor performance status (ECOG ≥2), inadequate organ or cardiac function, significant coagulation or proteinuria issues, or those unable to travel to the study site are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the drug could offer a new targeted radiotherapeutic option that shrinks tumors or controls disease for patients who have few remaining treatment choices.

How similar studies have performed: Radiolabeled Lutetium therapies have produced meaningful responses in prostate and neuroendocrine cancers, but using Lutetium [177Lu]-BL-ARC001 across a broad range of solid tumors is an early and largely untested approach.

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Sa Xiao, PHD

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