The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors (NCT07459283) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors
China10 participantsStarted 2026-04
Plain-language summary
This study is a prospective, single-arm, open-label, dose-escalation study. A total of 4 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. The dosing schedule and dose could also be adjusted according to the patient's condition. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged 18 to 75 years old male and female.
✓. Patients with advanced malignant solid tumors who have failed standard treatments.
✓. According to RECIST 1.1, there is at least one measurable lesion.
✓. ECOG performance status 0-1.
✓. Laboratory examination should meet: ①Blood routine: hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ( PLT) ≥100×10\^9/L; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula method
Exclusion criteria
✕. Received anti-tumor therapy within 4 weeks before enrollment.
✕. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
✕. Have undergone surgery within 4 weeks before enrollment.