Safety and dosing of 177Lu-INN805 in patients with malignant solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, dose-escalation trial enrolling adults with advanced malignant solid tumors who have exhausted standard therapies. Four predefined dose groups are tested every 6 weeks, with 1 to 4 cycles per participant and adjustments allowed based on safety, dosimetry, and preliminary efficacy. After each dose cohort completes observation for dose-limiting toxicity, dose escalation decisions are made to optimize safety and potential effectiveness. The study uses an INN805 radiopharmaceutical administered intravenously under close monitoring with RECIST 1.1 lesion assessment and regular laboratory checks. Primary aims focus on safety and dosimetry, with early signals of efficacy guiding subsequent dosing decisions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affiliated Hospital of Jiangnan University
  Wuxi, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Tingjin Wang
• Email: wangtingjin@find-cure.com
• Phone: 18664044814

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.