A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Solid Tumors

Sichuan Baili Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors

Treatments: Drug: BL-ARC002

Study type: Interventional

Funder types: Industry

Identifiers

NCT07591155

BL-ARC002-101

Details and patient eligibility

About

This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-ARC002 for injection in patients with locally advanced or metastatic solid tumors.

Full description

The study consists of two phases: a dose-escalation phase (Phase Ia) and an expansion phase (Phase Ib).

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

BL-ARC002

Experimental group

Description:

Participants receive BL-ARC002 for the first cycle (6 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Treatment:

Drug: BL-ARC002