Lutetium‑177 BL‑ARC001 for advanced or metastatic gastrointestinal and other solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, multicenter, non‑randomized Phase I study with a dose‑escalation phase (Phase Ia) followed by a cohort expansion phase (Phase Ib). Adult patients with measurable locally advanced or metastatic solid tumors, adequate organ function, and ECOG performance status 0–1 will receive escalating doses of Lutetium‑177 BL‑ARC001 to define safety, tolerability, and pharmacokinetics. The study will also collect preliminary evidence of antitumor activity using RECIST v1.1 and requires archival or fresh tumor tissue for correlative analyses. Safety assessments, laboratory monitoring, and imaging will guide dose selection for the expansion cohorts.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sichuan Cancer Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: 15013238943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.