68Ga/177Lu-NRT6020 imaging and targeted therapy for FAP-positive advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study begins with a safety and imaging stage using 68Ga-NRT6020 to define biodistribution, radiation dosimetry, pharmacokinetics, and how PET/CT results compare with 18F-FDG and FAP immunohistochemistry. Later stages enroll FAP-positive patients (selected by the 68Ga PET/CT companion diagnostic) for multi-center, multiple-dose administration of 177Lu-NRT6020 to assess tolerability, dosimetry, PK, and preliminary anti-tumor activity. Eligible participants have advanced solid tumors, measurable disease, and adequate organ function, with therapeutic stages focused on those who have failed or lack standard options. Imaging and safety endpoints guide dose confirmation and patient selection across centers in China.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Male or female participants aged 18-80;
2. 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);
3. Have at least one measurable lesion as per RECIST v1.1/PERCIST criteria;
4. For stage 2 and stage 3, a positive 68Ga-NRT6020 Injection PET/CT imaging results is required;
5. Participants must have adequate organ function;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Life expectancy ≥3 months;
8. For women of childbearing potential, a negative blood pregnancy test within 3 days before the first dose is required, and fertile male and female participants of childbearing potential must agree to use effective contraception with their partners from the signing of the informed consent form until 12 months after the last dose of the investigational drug.

Key Exclusion Criteria:

1. Known allergy to 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection, or any of their ingredients, such as alcohol;
2. Presence or suspicion of primary central nervous system tumors or intracranial metastasis;
3. 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.;
4. History of other malignancies within 5 years prior to the first dose of the investigational drug, excluding cured non-melanoma skin cancer, early-stage papillary thyroid cancer, and cervical carcinoma in situ;
5. Presence of severe or uncontrolled cardiac diseases requiring treatment;
6. High risk of bleeding;
7. Active syphilis or human immunodeficiency virus (HIV) antibody positive;
8. HBsAg-positive or HBcAb-positive with HBV-DNA levels above the detection limit;
9. Failure to alleviate previous antitumor treatment toxicities to Grade 0 or 1 according to CTCAE v5.0;
10. Participate in any other clinical trials within 1 month before the first dosing of 68Ga-NRT6020 Injection.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting
• Tianjin Medical University Cancer Insititute & Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Xinxing Zhang
• Email: xinxing.zhang@nrtmedtech.com
• Phone: +8602867534532

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.