Recruiting NCT07591155
A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BL-ARC002.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A 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
Overview
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.
Detailed description
The study consists of two phases: a dose-escalation phase (Phase Ia) and an expansion phase (Phase Ib).
Interventions
- Drug BL-ARC002
Administration by intravenous infusion for a cycle of 6 weeks.
Primary outcome measures
- Phase Ia: Dose limiting toxicity (DLT) [Time frame: Up to 42 days after the first dose]
- Phase Ia: Maximum tolerated dose (MTD) [Time frame: Up to 42 days after the first dose]
- Phase Ib: Recommended Phase II Dose (RP2D) [Time frame: Up to approximately 24 months]
Secondary outcome measures (11)
- Treatment-Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]
- Cmax [Time frame: Up to approximately 24 months]
- Tmax [Time frame: Up to approximately 24 months]
- T1/2 [Time frame: Up to approximately 24 months]
- AUC0-t [Time frame: Up to approximately 24 months]
- CL (Clearance) [Time frame: Up to approximately 24 months]
- Ctrough [Time frame: Up to approximately 24 months]
- ADA (anti-drug antibody) [Time frame: Up to approximately 24 months]
- Phase Ib: Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
- Phase Ib: Disease Control Rate (DCR) [Time frame: Up to approximately 24 months]
- Phase Ib: Duration of Response (DOR) [Time frame: Up to approximately 24 months]
Eligibility criteria
Inclusion criteria
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
- Expected survival time ≥3 months;
- Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment;
- Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 2 years;
- Must have at least one measurable lesion as defined by RECIST v1.1;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
- Organ function levels must meet the required criteria;
- Coagulation function: International normalized ratio ≤1.5 and activated partial thromboplastin time ≤1.5 × upper limit of normal;
- Urine protein ≤2+ or ≤1000 mg/24 hours;
- 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
- Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
- History of serious heart disease;
- QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of another malignancy within 5 years prior to the first dose;
- Hypertension inadequately controlled by two antihypertensive medications;
- History of ILD requiring steroid therapy, current ILD, or ≥ Grade 2 radiation pneumonitis;
- Active symptoms of central nervous system metastasis;
- History of allergy to recombinant humanized or human-mouse chimeric antibodies, or allergy to any excipient component of BL-ARC002;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Cumulative anthracycline dose > 360 mg/m² from prior (neo)adjuvant anthracycline-based therapy;
- Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infection requiring systemic therapy;
- Participation in another clinical trial within 4 weeks prior to the first dose;
- Pregnancy or breastfeeding;
- Study participants with claustrophobia or any condition preventing them from lying still to complete examinations;
- Other conditions deemed by the investigator to make the participant unsuitable for this clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Cancer Hospital — Tianjin
Identifiers
NCT: NCT07591155 · BL-ARC002-101