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

FindCure Biosciences

Status and phase: Enrolling; Early Phase 1

Conditions: Breast Cancer; Sarcoma; Lung Cancer - Non Small Cell Squamous; Thyroid Cancer; Head & Neck Cancer; Maligant Solid Tumor

Treatments: Drug: INN805

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07459283

INN805-IIT-02

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

INN805 injection

Experimental group

Treatment:

Drug: INN805