NCT07274852 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
| NCT ID | NCT07274852 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan Baili Pharmaceutical Co., Ltd. |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 22 participants in total. It began in 2025-12-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07274852 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07274852 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07274852 currently recruiting?
Yes, NCT07274852 is actively recruiting participants. Contact the research team at xiaosa@baili-pharm.com for enrollment information.
Where is the NCT07274852 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07274852 clinical trial?
NCT07274852 is sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. The trial plans to enroll 22 participants.
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