177Lu-INN805 radioactive treatment for adults with advanced solid tumors
Tests 177Lu-INN805 for safety and dosing in adults with solid tumors.
Key facts
- Who runs it
- FindCure Biosciences (ZhongShan) Co., Ltd.
- Where
- Wuxi, ChinaSee the site
- Trial code
- Registry title
- The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 10 people, planned
- Started
- 20 Apr 2026
- Expected to end
- Mar 2027
- Type of study
- Interventional
- Treatments tested
- INN805
- Record updated
- 4 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors whose standard treatments have not worked. It tests the safety and effect of a radioactive drug, 177Lu-INN805.
- Age
- 18 to 75 years
- Sex
- Men and women
- Disease stage
- Advanced malignant solid tumors with at least one measurable lesion (RECIST 1.1).
- Earlier treatment
- Standard treatments must have failed. No anti-tumor therapy and no other trial drug in the 4 weeks before joining.
Main reasons for not taking part
- Anti-tumor therapy within 4 weeks before joining
- Surgery within 4 weeks before joining
- Not yet recovered from side effects of earlier cancer treatment (CTCAE grade 1 or higher)
- Brain or spinal cord metastases that cause symptoms
- Any situation the researcher considers unsuitable for the trial
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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: 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
Who cannot take part
- 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
- Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1)
- Central nervous system metastases with clinical symptoms
- With any situations that the researcher considers inappropriate to participate in this research
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Affiliated Hospital of Jiangnan UniversityWuxi, ChinaContact: Chunjing YuTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- INN805 injectionTreatment being tested
Treatment: INN805
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-INN805 Injection in Patients With Malignant Solid Tumors
- Plain-language title
- 177Lu-INN805 radioactive treatment for adults with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07459283, who can take part
- Record updated
- 4 September 2026