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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma; Breast Cancer; Thyroid Cancer; Lung Cancer - Non Small Cell Squamous; Head & Neck Cancer; Maligant Solid Tumor
• Intervention / Treatment: Drug: INN805

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Tingjin Wang; Phone Number: 18664044814; Email: wangtingjin@find-cure.com

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Affiliated Hospital of Jiangnan University
      • Contact: chunjing Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INN805 injection	Drug: INN805; The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	To explore the clinical effectiveness. Tumor response based on RECIST 1.1	Approximately 12 months
Disease control rate (DCR)	DCR as assessed using RECIST 1.1	Approximately 12 months
Progression free survival (PFS)	PFS as assessed using RECIST 1.1	Approximately 12 months

Collaborators and Investigators

• Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.
• Collaborators: Affiliated Hospital of Jiangnan University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Skin Diseases; Breast Diseases; Neoplasms, Connective and Soft Tissue; Thyroid Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Head and Neck Neoplasms; Sarcoma; Thyroid Neoplasms
• Other Study ID Numbers: INN805-IIT-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No