Actively Recruiting
Safety and Tolerability Study of 68Ga-NRT6020 and 177Lu-NRT6020 Injections in FAP-Positive Adults With Advanced Solid Tumors
Led by Chengdu New Radiomedicine Technology Co. LTD. · Updated on 2026-02-02
132
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of two investigational drugs, 68Ga-NRT6020 Injection and 177Lu-NRT6020 Injection, in people with advanced solid tumors that have not responded to standard treatments or for whom no standard options exist. The study is divided into three stages: the first focuses on safety and imaging comparisons, the second on safety and tolerability in patients with a specific marker (FAP-positive), and the third on finding the recommended dose and early signs of the drugs' effects. This trial is sponsored by Chengdu New Radiomedicine Technology Co. LTD. During stage 1, participants receive a single intravenous dose of 68Ga-NRT6020 Injection at either a low or high dose, followed by PET/CT scans to assess drug distribution and imaging characteristics. Stage 2 involves multiple doses of 177Lu-NRT6020 Injection administered every six weeks or as determined by the safety review committee, with dose escalation to identify the best dose, alongside ongoing 68Ga-NRT6020 use. Stage 3 continues with multiple doses of 177Lu-NRT6020 Injection to confirm the recommended dose and assess preliminary efficacy, while also monitoring imaging and pharmacokinetics. Participants undergo various assessments throughout the study, including PET/CT imaging, blood tests to measure drug levels and radiation doses, and evaluations of tumor response and safety over about one year. Researchers track side effects, dose limits, and how the drugs move through the body. The study includes regular monitoring of adverse events and treatment responses, and participants must meet specific health and tumor criteria to enroll.
CONDITIONS
Brief 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
- Advanced solid tumor patients who have failed prior standard therapies or are unsuitable for standard therapies (stage 2 and stage 3)
- At least one measurable lesion as per RECIST v1.1 or PERCIST criteria
- Positive 68Ga-NRT6020 PET/CT imaging results (stage 2 and stage 3)
- Adequate organ function
- ECOG performance status of 0 or 1
- Life expectancy of 3 months or more
- Negative pregnancy test for women of childbearing potential within 3 days before first dose
- Fertile participants must agree to use effective contraception from consent until 12 months after last dose
You will not qualify if you...
- Known allergy to 68Ga-NRT6020, 177Lu-NRT6020, or their ingredients such as alcohol
- Presence or suspicion of primary central nervous system tumors or intracranial metastasis
- Received antitumor treatments within 7 days before dosing (stage 1) or within 4 weeks before dosing (stage 2 and stage 3)
- History of other malignancies within 5 years, except certain cured cancers
- Severe or uncontrolled cardiac diseases requiring treatment
- High risk of bleeding
- Active syphilis or HIV antibody positive
- Positive hepatitis B surface antigen or core antibody with high HBV-DNA levels
- Toxicities from previous antitumor treatment not resolved to Grade 0 or 1
- Participation in other clinical trials within 1 month before first dosing of 68Ga-NRT6020 Injection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Within 24 hours
Participants receive a single intravenous injection of 68Ga-NRT6020 Injection followed by PET/CT scans to determine eligibility for further treatment.
1 visit (in-person) for injection and scans
Duration - Up to approximately 36 weeks (6 cycles every 6 weeks)
Participants receive multiple intravenous injections of 177Lu-NRT6020 Injection administered every 6 weeks or at other intervals determined by the Safety Review Committee, for up to 6 cycles to treat advanced solid tumors.
Up to 6 visits (in-person) for injections every 6 weeks
Duration - Up to 1 year
Participants are monitored for safety, adverse events, and treatment response for up to 1 year after the treatment period.
Periodic visits for safety and efficacy assessments during follow-up
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
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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