BL-ARC002 in patients with advanced 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 a Phase 1, open-label, multicenter, non-randomized trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of BL-ARC002 injections in adults with locally advanced or metastatic solid tumors. The study includes a dose-escalation phase (Phase Ia) and an expansion cohort phase (Phase Ib). Eligible participants have measurable disease, adequate organ function, and prior therapy considerations, with tissue samples available for research. Outcomes focus on safety and pharmacokinetics, with preliminary signals of efficacy as a secondary objective.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
2. No gender restriction;
3. Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
4. Expected survival ≥3 months;
5. Locally advanced or metastatic esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, or other solid tumors;
6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions obtained within 2 years;
7. Must have at least one measurable lesion as defined by RECIST v1.1;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
11. Organ function levels must meet the protocol-specified requirements;
12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);
13. Urine protein ≤2+ or ≤1000 mg/24h;
14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days prior to the start of treatment, with a negative serum pregnancy test result, and they must be non-lactating; all study participants (both male and female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the completion of treatment.

Exclusion Criteria:

1. Use of chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;
2. History of severe cardiac disease;
3. QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
4. Active autoimmune diseases and inflammatory diseases;
5. Diagnosis of another malignant tumor within 5 years prior to the first dose;
6. Hypertension inadequately controlled by two antihypertensive agents;
7. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of Grade ≥2;
8. Active central nervous system (CNS) metastases;
9. Subjects with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-ARC002;
10. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
11. Cumulative anthracycline dose \> 360 mg/m² from prior (neo)adjuvant anthracycline-based therapy;
12. Positive for human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
13. Active infection requiring systemic therapy;
14. Participation in another clinical trial within 4 weeks prior to the first dose;
15. Pregnant or breastfeeding women;
16. Subjects with claustrophobia or inability to lie flat for the duration of required examinations due to various reasons;
17. Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: +8615013238943

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.