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OncoMatch/Clinical Trials/NCT07232407

A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

Is NCT07232407 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Lutetium [177Lu] BL-ARC001 for gastrointestinal tumors.

Phase 1RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT07232407Data as of Jun 2026Location: China

Treatment: Lutetium [177Lu] BL-ARC001This 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.

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Extracted eligibility criteria

Treatments studied

Other

Lutetium [177Lu] BL-ARC001

Cancer type

Colorectal Cancer

Gastric Cancer

Hepatocellular Carcinoma

Pancreatic Cancer

Cholangiocarcinoma

Esophageal Carcinoma

Tumor Agnostic

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

Cannot have received: chemotherapy

Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose

Cannot have received: biotherapy

Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose

Cannot have received: immunotherapy

Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose

Cannot have received: anthracycline

Exception: cumulative dose ≤ 360 mg/m² in previous (neo)adjuvant anthracycline therapy

Cumulative dose of anthracyclines > 360 mg/m² in previous (neo)adjuvant anthracycline therapy

Lab requirements

Blood counts

Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN; Urine protein ≤2+ or ≤1000mg/24h

Kidney function

Liver function

Cardiac function

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; No severe cardiac dysfunction, left ventricular ejection fraction ≥50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07232407 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy, biotherapy, immunotherapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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