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Clinical Trials in China / NCT07459283
Recruiting Early Phase 1

The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors

NCT07459283 · tracked via the Priya Life Science China tracker
Sponsor
FindCure Biosciences (ZhongShan) Co., Ltd
Phase
Early Phase 1
Started
2026-04-20
Last updated
2026-09-04

Condition(s) studied

Maligant Solid TumorHead & Neck CancerThyroid CancerLung Cancer - Non Small Cell SquamousBreast CancerSarcoma

Investigational drug(s) / intervention(s)

INN805

INN805: The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 18 to 75 years old male and female. 2. Patients with advanced malignant solid tumors who have failed standard treatments. 3. According to RECIST 1.1, there is at least one measurable lesion. 4. ECOG performance status 0-1. 5. Laboratory examination should meet: ① Blood 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: 1. Received anti-tumor therapy within 4 weeks before enrollment. 2. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period. 3. Have undergone surgery within 4 weeks before enrollment. 4. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1). 5. Central nervous system metastases with clinical symptoms. 6. With any situations that the researcher considers inappropriate to participate in this research.

Primary outcome measure(s)

  • Determine dose-limiting toxicity (DLT) — 42 days after first dose
    Determine the DLT of INN805
  • Frequency of adverse events (AEs) and SAEs — Approximately 12 months
    To investigate the safety characteristics of INN805
  • Determine the Maximum Tolerated Dose (MTD) — Approximately 12 months
    Determine the MTD of INN805

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Jiangnan University Wuxi Jiangsu Recruiting

More FindCure Biosciences (ZhongShan) Co., Ltd. trials in China

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A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07459283 on ClinicalTrials.gov ↗ ← All trials in China