RecruitingPhase 1NCT07232407

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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Lutetium [177Lu] BL-ARC001 Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

22 participants

Start Date

Nov 14, 2025

Study Type

INTERVENTIONAL

Conditions

Solid Tumors Gastrointestinal Tumors

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria14

Voluntarily sign the informed consent form and comply with the protocol requirements;
Gender: no restriction;
Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
Expected survival time ≥3 months;
Locally advanced or metastatic solid tumors;
Agree 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 meeting the RECIST v1.1 criteria;
ECOG performance status score of 0 or 1;
Toxicities from prior antitumor therapy have 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 ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;
Urine protein ≤2+ or ≤1000mg/24h;
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 Criteria16

Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose;
History of severe heart disease;
QT interval prolongation, 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 steroid treatment, current ILD, or ≥ Grade 2 radiation pneumonitis;
Symptoms of active central nervous system metastases;
History of allergy to recombinant humanized or chimeric antibodies, or allergy to any excipient of Lutetium \[177Lu\] BL-ARC001;
Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
Cumulative dose of anthracyclines \> 360 mg/m² in previous (neo)adjuvant anthracycline therapy;
Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
Active infection requiring systemic treatment;
Participation in another clinical trial within 4 weeks prior to the first dose;
Pregnant or lactating women;
Any other condition deemed by the investigator as unsuitable for participation in this clinical trial.