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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 (May 2026). This Phase 1 trial studies Lutetium [177Lu] BL-ARC001 for gastrointestinal tumors.

Phase 1RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT07232407Data as of May 2026

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

Cancer type

Colorectal Cancer

Gastric Cancer

Hepatocellular Carcinoma

Pancreatic Cancer

Cholangiocarcinoma

Esophageal Carcinoma

Tumor Agnostic

Performance status

ECOG 0–1(Restricted strenuous activity)

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.

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