Lutetium‑177 BL‑ARC001 for advanced or metastatic gastrointestinal 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

This trial will test whether Lutetium‑177 BL‑ARC001 is safe and shows early benefit in adults with locally advanced or metastatic gastrointestinal or other solid tumors.

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: NCT07232407 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with locally advanced or metastatic solid tumors, at least one measurable lesion, ECOG 0–1, adequate organ and coagulation function, recovery from prior therapy toxicities, and willingness to provide tumor tissue and attend study visits.

Not a fit: Patients with poor performance status (ECOG >1), very limited life expectancy, uncontrolled comorbidities, significant cardiac dysfunction, inadequate organ or coagulation parameters, or who cannot comply with visits or tissue submission are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the drug could provide a new radioligand therapy option that helps control or shrink tumors in some patients with advanced gastrointestinal or other solid tumors.

How similar studies have performed: Lutetium‑177 radioligand therapies have produced clear benefits in specific cancers (for example, neuroendocrine tumors and prostate cancer), but applying this approach broadly to gastrointestinal and many other solid tumors is relatively novel and less proven.

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.

Where this trial is running

Chengdu, Sichuan

• Sichuan Cancer Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Gastrointestinal Tumors; Solid Tumors