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New treatment option for Gastrointestinal Tumors
Official title A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
ClinicalTrials.gov ID: NCT07232407
What this study is testing
What is Lutetium [177Lu] BL-ARC001?
Lutetium [177Lu] BL-ARC001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastrointestinal tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.