Recruiting NCT07232407
A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other 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: Lutetium [177Lu] BL-ARC001.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Tumors, 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, Pharmacokinetics, and Preliminary Efficacy of Lutetium [177Lu] BL-ARC001 Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
Overview
This study is an open-label, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of Lutetium \[177Lu\] BL-ARC001 in patients with locally advanced or metastatic solid tumors.
Detailed description
The study is divided into two phases: a dose escalation phase (Phase Ia) and a cohort expansion phase (Phase Ib).
Interventions
- Drug Lutetium [177Lu] BL-ARC001
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 (12)
- 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]
- Distribution Characteristics [Time frame: Up to approximately 24 months]
- Radiation Characteristics [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]
Eligibility criteria
Inclusion criteria
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Gender: no restriction;
- Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
- Expected survival time ≥3 months;
- Locally advanced or metastatic solid tumors;
- Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 3 years;
- Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
- ECOG performance status score of 0 or 1;
- Toxicities from prior antitumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- Organ function levels must meet the requirements;
- Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;
- Urine protein ≤2+ or ≤1000mg/24h;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and must not be breastfeeding; all enrolled patients (regardless of gender) should use adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.
Exclusion criteria
- Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose;
- History of severe heart disease;
- QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
- Active autoimmune or inflammatory diseases;
- Diagnosis of other malignancies within 5 years prior to the first dose;
- Hypertension poorly controlled by two antihypertensive medications;
- History of interstitial lung disease (ILD) requiring steroid treatment, current ILD, or ≥ Grade 2 radiation pneumonitis;
- Symptoms of active central nervous system metastases;
- History of allergy to recombinant humanized or chimeric antibodies, or allergy to any excipient of Lutetium \[177Lu\] BL-ARC001;
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Cumulative dose of anthracyclines > 360 mg/m² in previous (neo)adjuvant anthracycline therapy;
- Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infection requiring systemic treatment;
- Participation in another clinical trial within 4 weeks prior to the first dose;
- Pregnant or lactating women;
- Any other condition deemed by the investigator as unsuitable for participation in 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
- Sichuan Cancer Hospital — Chengdu
Identifiers
NCT: NCT07232407 · 177Lu-BL-ARC001-102