Actively Recruiting
Safety Trial of 68Ga/177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients
Led by Chengdu New Radiomedicine Technology Co. LTD. · Updated on 2026-02-02
132
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety Trial of 68Ga/177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18-80
- Histologically or cytologically confirmed advanced solid tumors
- Patients who have failed prior standard therapies or are unsuitable for standard therapies (stage 2 and 3 only)
- At least one measurable lesion according to RECIST v1.1/PERCIST criteria
- Positive 68Ga-NRT6020 PET/CT imaging results (required for stage 2 and 3)
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 3 months or more
- Negative pregnancy test within 3 days before first dose for women of childbearing potential
- Agreement to use effective contraception from consent until 12 months after last dose (for fertile participants of childbearing potential)
You will not qualify if you...
- Known allergy to 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection, or any ingredients such as alcohol
- Presence or suspicion of primary central nervous system tumors or brain metastases
- Prior antitumor treatments within 7 days before dosing in stage 1; within 4 weeks before dosing in stages 2 and 3
- History of other cancers within 5 years, excluding certain cured cancers
- Severe or uncontrolled heart disease requiring treatment
- High risk of bleeding
- Active syphilis or HIV positive
- Positive for hepatitis B surface or core antigen with detectable HBV-DNA levels
- Unresolved toxicities from previous antitumor treatments above Grade 1
- Participation in other clinical trials within 1 month before first dosing of 68Ga-NRT6020 Injection
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
2
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, China
Actively Recruiting
Research Team
X
Xinxing Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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