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.
Male or female participants aged 18-80;
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);
Have at least one measurable lesion as per RECIST v1.1/PERCIST criteria;
For stage 2 and stage 3, a positive 68Ga-NRT6020 Injection PET/CT imaging results is required;
Known allergy to 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection, or any of their ingredients, such as alcohol;
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.;
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;
Sequential
68Ga-NRT6020 Injection
Diagnostic testParticipants will receive a single intravenous injection of 68Ga-NRT6020 Injection (3 mCi or 5 mCi) and PET/CT scans at multiple time points.
177Lu-NRT6020 Injection (stage 2)
DrugIt is planned to evaluate 4 dose levels of 177Lu-NRT6020 Injection: 50mCi, 100mCi, 150mCi and one/more adaptive dose groups (ranged from 150 to 250 mCi, the specific doses and/or doses with other frequencies within the range of 150\~250mCi, need to be determined after the completion of the dose-limiting toxicity (DLT) assessment for the previous three dose groups, in combination with the safety, pharmacokinetics and radiation dosimetry results of the participants, following confirmation by the SRC) which will be administered every 6 weeks (Q6W), and/or other dosing intervals determined by the SRC, for up to 6 cycles.
177Lu-NRT6020 Injection (stage 3)
DrugParticipants will receive intravenous injection of 177Lu-NRT6020 Injection, administered Q6W and/or other dosing intervals determined by the SRC, for up to 6 cycles.
Adverse events
Occurrence of adverse events
Dose-limiting toxicity (DLT) (stage 2)
Evaluate the safety and tolerability of 177Lu-NRT6020
Maximum tolerated dose (MTD) (if any) or recommended dose for expansion study of 177Lu-NRT6020 Injection (stage 2)
Evaluating the safety and tolerability of 177Lu-NRT6020 with the aim of determining the optimal dose
RP2D for 177Lu-NRT6020 Injection (stage 3)
Determine the optimal dose of 177Lu-NRT6020
Standardized uptake values (SUV) (stage 1)
Evaluate the distribution of 68Ga-NRT6020 Injection in various tissues and organs of the human body
Absorbed dose (stage 1)
Evaluate the dosimetry characteristics of 68Ga-NRT6020 Injection in various tissues and organs of the human body
Effective dose (stage 1)
Evaluate the dosimetry characteristics of 68Ga-NRT6020 Injection in the human body
Scanning time window (stage 1)
Compare the imaging parameter in different timepoints and different doses
Consistency of 68Ga-NRT6020 Injection PET/CT imaging
Evaluate the consistency between 68Ga-NRT6020 Injection PET/CT imaging and 18F-FDG PET/CT imaging results, as well as the consistency of 68Ga-NRT6020 Injection PET/CT imaging with FAP IHC results.
Scanning time window (stage 2)
Compare the imaging parameter in different timepoints and different doses
Imaging dose of 68Ga-NRT6020 Injection (stage 3)
Compare the imaging parameter under different doses in order to select the optimal imaging dose
Scanning time window (stage 3)
Compare the imaging parameter in different timepoints and different doses
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