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OncoMatch/Clinical Trials/NCT06883539

A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.

Is NCT06883539 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies LXP1788 is administered intravenously via Port-A for solid tumor malignancies, cancer.

Phase 1RecruitingLaunXP Biomedical Co., Ltd.NCT06883539Data as of May 2026

Treatment: LXP1788 is administered intravenously via Port-AA Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor. Patients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected. The main questions it aims to answer are: 1. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection 2. To evaluate the pharmacokinetics (PK) of LXP1788 Injection

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Hepatocellular Carcinoma

Renal Cell Carcinoma

Pancreatic Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

Absolute neutrophil count (ANC) < 1.5 x 10^9/L; Platelet count < 100 x 10^9/L; Hemoglobin < 9 g/dL; Having had a blood transfusion within 2 weeks of screening date is also not allowed.

Kidney function

Estimated creatinine clearance (CrCL) < 60 mL/min per the Cockcroft and Gault formula

Liver function

Total bilirubin > 1.5 x ULN; AST and ALT > 3 x ULN if no liver metastases; AST and ALT > 5 x ULN in the presence of liver metastases

Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: Bone marrow: ANC < 1.5 x 10^9/L; Platelet count < 100 x 10^9/L; Hemoglobin < 9 g/dL; Having had a blood transfusion within 2 weeks of screening date is also not allowed. Hepatic: Total bilirubin > 1.5 x ULN; AST and ALT > 3 x ULN if no liver metastases; AST and ALT > 5 x ULN in the presence of liver metastases. Renal: Estimated creatinine clearance (CrCL) < 60 mL/min per the Cockcroft and Gault formula

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

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