177Lu-labeled NY108 SPECT Imaging in Patients

NCT05815394 | Unknown Early Phase 1

• 1 other identifier: LS2023013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)

  Biodistribution of 177Lu-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 177Lu-SPECT scans will be reported.

  1 year

• Incidence of Treatment-Emergent Adverse Events

  Safety will be assessed by evaluation of incidence of adverse events.

  1 year

Study Arms (1)

177Lu-Anti-PSMA mAbs

EXPERIMENTAL

Drug: 177Lu-labeled NY108

Interventions

177Lu-labeled NY108 DRUG

Patients will receive a tracer (40-60ug) dose of 177Lu(28.5-31.5mCi) labelled NY108.

177Lu-Anti-PSMA mAbs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily signed informed consent;
• Age 18-75, male;
• Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis;
• Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive;
• Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen;
• Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria;
• An ECOG score of 0-2

You may not qualify if:

• Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
• Patients with severe systemic or localized infections or other serious coexisting diseases;
• Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc;
• Patients with autoimmune diseases, including rheumatoid, etc;
• Inadequately controlled arrhythmias, including atrial fibrillation:
• Cardiac insufficiency (New York Heart Association (NYHA) work class criteria);
• Uncontrolled hypertension;
• Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies;
• Subjects positive for syphilis, HBV, HCV, FIIV;
• Subjects of childbearing age who are unable to use effective contraceptive devices:
• Patients with a history of mental illness or related medical conditions;
• Patients who are unable or unavailable for SPECT/CT scanning;
• Other subjects who, in the opinion of the investigator, are not suitable for enrollment.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Chunjing Yu

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunjing Yu

CONTACT

15312238622; ycj_wxd1978@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: March 3, 2023
• Primary Completion: March 3, 2024
• Study Completion: December 12, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)