TheranosticTrials.org

Clinical Trial · NCT06911489

Safety Trial of 68Ga/177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients

Overview

Stage 1 (Safety study for 68Ga-NRT6020 Injection): The goal of this clinical trial stage is to evaluate the safety of 68Ga-NRT6020 Injection in participants with advanced solid tumors. The study will also assess the biodistribution, radiation dosimetry, imaging profile, and pharmacokinetics of the drug. Additionally, researchers aim to investigate how consistent the PET/CT imaging results of 68Ga-NRT6020 are with 18F-FDG PET/CT imaging and FAP immunohistochemistry (IHC) results. Stage 2 (Safety and tolerability study for 177Lu-NRT6020 Injection): This stage focuses on evaluating the safety and tolerability of 177Lu-NRT6020 Injection in FAP-positive participants with advanced solid tumors. Researchers will also assess the safety of 68Ga-NRT6020 Injection in this population. The study will evaluate the biodistribution, radiation dosimetry, pharmacokinetics, and preliminary efficacy of 177Lu-NRT6020 Injection. Additionally, the imaging profile of 68Ga-NRT6020 and its consistency with other imaging techniques will be further investigated. Stage 3 (Preliminary efficacy study for 68Ga/177Lu-NRT6020 Injection): The objective of this stage is to evaluate the safety of 177Lu-NRT6020 Injection and 68Ga-NRT6020 Injection in FAP-positive participants with advanced solid tumors, as well as to determine the recommended phase 2 dose (RP2D) of 177Lu-NRT6020 Injection. The study will also assess the preliminary efficacy, biodistribution, radiation dosimetry, and pharmacokinetics of the drugs. Furthermore, researchers will investigate the imaging profile of 68Ga-NRT6020 and its consistency with other imaging techniques.

Sponsor

Chengdu New Radiomedicine

Phase

Phase 1

Contacts

Xinxing Zhang (CONTACT)

xinxing.zhang@nrtmedtech.com

+8602867534532

ClinicalTrials.gov

NCT06911489

Drug / Compound

NRT6020

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

NRT6020

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules

Eligibility

Inclusion

  • For stage 2 and stage 3, a positive 68Ga-NRT6020 Injection PET/CT imaging results is required;
  • Histologically or cytologically confirmed advanced solid tumors; advanced solid tumors patients who have failed prior standard therapies or deemed unsuitable for standard therapies (only for stage 2 and stage 3);
  • Participants must have adequate organ function;
  • Life expectancy ≥3 months;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Have at least one measurable lesion as per RECIST v1.1/PERCIST criteria;

Exclusion

  • HBsAg-positive or HBcAb-positive with HBV-DNA levels above the detection limit;
  • Presence or suspicion of primary central nervous system tumors or intracranial metastasis;
  • For stage 1: Received prior antitumor treatments within 7 days before the investigational drug dosing, and/or plan to receive antitumor treatments during the safety observation period; For stage 2 and stage 3: Received prior antitumor treatments within 4 weeks before the initial investigational drug dosing, including chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc.;
  • Participate in any other clinical trials within 1 month before the first dosing of 68Ga-NRT6020 Injection.
  • Known allergy to 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection, or any of their ingredients, such as alcohol;
  • Failure to alleviate previous antitumor treatment toxicities to Grade 0 or 1 according to CTCAE v5.0;
  • High risk of bleeding;
  • Presence of severe or uncontrolled cardiac diseases requiring treatment;
  • Active syphilis or human immunodeficiency virus (HIV) antibody positive;