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

Recruiting now · Phase 1

Conditions studied: Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma, Solid Tumors

In brief

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.

Key facts

Study ID: NCT07274852
Run by: Sichuan Baili Pharmaceutical Co., Ltd.
People needed: 22
Starts: 2025-12-10
Expected to finish: 2027-12-01
Last updated by the study team: 2026-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Use of chemotherapy, biological therapy, or immunotherapy within 4 weeks or 5 half-lives prior to the first dose;
History of severe heart disease;
Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;
Active autoimmune or inflammatory diseases;
Diagnosis of other malignancies within 5 years prior to the first dose;
Hypertension poorly controlled by two antihypertensive medications;
History of interstitial lung disease (ILD) requiring hormonal therapy, current ILD, or ≥ Grade 2 radiation pneumonitis;
Symptoms of active central nervous system metastasis;
History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of 177Lu-BL-ARC001;
Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
Cumulative dose of anthracyclines >360 mg/m² during prior (neo)adjuvant anthracycline therapy;
Positive human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
Participation in another clinical trial within 4 weeks prior to the first dose;
Pregnant or lactating women;
Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Where it is running

West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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