BL-ARC002 in patients with 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, dose-escalation and expansion Phase I trial of BL-ARC002. It aims to characterize safety, tolerability, pharmacokinetics, and preliminary efficacy in adults with locally advanced or metastatic solid tumors that have progressed after standard treatments. The study includes a dose-escalation part (Phase Ia) followed by an expansion part (Phase Ib) to further evaluate dosing and early signals of activity. Participants must have measurable disease, adequate organ function, and provide tumor tissue samples when available. Enrollment is conducted at selected centers in China, under a lead sponsor and collaborators.

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. No gender restrictions;
3. Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
4. Expected survival time ≥3 months;
5. Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment;
6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 2 years;
7. Must have at least one measurable lesion as defined by RECIST v1.1;
8. Eastern Cooperative Oncology Group performance status of 0 or 1;
9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
11. Organ function levels must meet the required criteria;
12. Coagulation function: International normalized ratio ≤1.5 and activated partial thromboplastin time ≤1.5 × upper limit of normal;
13. Urine protein ≤2+ or ≤1000 mg/24 hours;
14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test being negative, and they must not be breastfeeding; all enrolled patients (regardless of sex) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.

Exclusion Criteria:

1. Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
2. History of serious heart 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 malignancy within 5 years prior to the first dose;
6. Hypertension inadequately controlled by two antihypertensive medications;
7. History of ILD requiring steroid therapy, current ILD, or ≥ Grade 2 radiation pneumonitis;
8. Active symptoms of central nervous system metastasis;
9. History of allergy to recombinant humanized 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 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. Pregnancy or breastfeeding;
16. Study participants with claustrophobia or any condition preventing them from lying still to complete examinations;
17. Other conditions deemed by the investigator to make the participant unsuitable for this clinical trial.

Where it's running

• Tianjin Cancer Hospital
  Tianjin, Tianjin Municipality, 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.