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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.
During the study, 68Ga-NRT6020 served as the companion diagnostic agent for 177Lu-NRT6020 to select eligible patients. This stage 2 and stage 3 of the study is designed as a multi-center, multiple-dose, parallel-cohort study, and will enroll FAP-positive (FAP-positive is defined by positive PET/CT imaging results for 68Ga-NRT6020; and dose of 68Ga-NRT6020 will be confirmed by the SRC after stage 1) patients with advanced solid tumors who have failed or have no available standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NRT6020 Injection (stage 1) | Experimental | Stage 1 is designed as a single-arm, single-dose study, planning to enroll participants with advanced solid tumors, with two planned dose groups: a low-dose group and a high-dose group. The dose groups are sequentially enrolled from low to high, with 6 participants planned for enrollment in each dose group. |
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| 68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 2) | Experimental | Stage 2 is designed as a single-arm, multiple-dose, "3+3" dose-escalation study, and will enroll FAP-positive patients with advanced solid tumors who have failed or have no available standard therapy. |
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| 68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 3) | Experimental | This stage 3 of the study is designed as a multi-center, single-arm, multiple-dose, parallel-cohort study, and will enroll FAP-positive patients with advanced solid tumors who have failed or have no available standard therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NRT6020 Injection | Diagnostic Test | Participants will receive a single intravenous injection of 68Ga-NRT6020 Injection (3 mCi or 5 mCi) and PET/CT scans at multiple time points. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Occurrence of adverse events | Through study completion, an average of 1 year |
| Dose-limiting toxicity (DLT) (stage 2) | Evaluate the safety and tolerability of 177Lu-NRT6020 | After the first dose of 177Lu-NRT6020 administration, up to 42 days |
| 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 | Through study completion, an average of 1 year |
| RP2D for 177Lu-NRT6020 Injection (stage 3) | Determine the optimal dose of 177Lu-NRT6020 | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake values (SUV) (stage 1) | Evaluate the distribution of 68Ga-NRT6020 Injection in various tissues and organs of the human body | After the administration of 68Ga-NRT6020, within 24 hours |
| Absorbed dose (stage 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After the administration of 68Ga-NRT6020, within 3 hours |
| Scanning time window (stage 2) |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinxing Zhang | Contact | +8602867534532 | xinxing.zhang@nrtmedtech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| 177Lu-NRT6020 Injection (stage 2) | Drug | It 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. |
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| 177Lu-NRT6020 Injection (stage 3) | Drug | Participants will receive intravenous injection of 177Lu-NRT6020 Injection, administered Q6W and/or other dosing intervals determined by the SRC, for up to 6 cycles. |
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Evaluate the dosimetry characteristics of 68Ga-NRT6020 Injection in various tissues and organs of the human body
| After the administration of 68Ga-NRT6020, within 24 hours |
| Effective dose (stage 1) | Evaluate the dosimetry characteristics of 68Ga-NRT6020 Injection in the human body | After the administration of 68Ga-NRT6020, within 24 hours |
| Scanning time window (stage 1) | Compare the imaging parameter in different timepoints and different doses | After the administration of 68Ga-NRT6020, within 3 hours |
| Radioactivity in biological specimen (stage 1) | Detect the radioactivity in specimen samples at various time points | After the administration of 68Ga-NRT6020, within 24 hours |
| Peak Plasma Concentration (Cmax) of 68Ga-NRT6020 (stage 1) | Multiple blood samples will be collected to determine the pharmacokinetic profiles of 68Ga-NRT6020 Injection | After the administration of 68Ga-NRT6020, within 24 hours |
| Time to reach maximum concentration (Tmax) of 68Ga-NRT6020 (stage 1) | Multiple blood samples will be collected to determine the pharmacokinetic profiles of 68Ga-NRT6020 Injection | After the administration of 68Ga-NRT6020, within 24 hours |
| Area under the plasma concentration versus time curve (AUC) of 68Ga-NRT6020 Injection (stage 1) | Multiple blood samples will be collected to determine the pharmacokinetic profiles of 68Ga-NRT6020 Injection | After the administration of 68Ga-NRT6020, within 24 hours |
| Half life (t1/2) of 68Ga-NRT6020 (stage 1) | Multiple blood samples will be collected to determine the pharmacokinetic profiles of 68Ga-NRT6020 Injection | After the administration of 68Ga-NRT6020, within 24 hours |
| Standardized uptake values (SUV) (stage 2 and stage 3) | Evaluate the distribution of 177Lu-NRT6020 Injection in various tissues and organs of the human body | After the administration of 177Lu-NRT6020, at least 7 days |
| Absorbed dose (stage 2 and stage 3) | Evaluate the dosimetry characteristics of 177Lu-NRT6020 Injection in various tissues and organs of the human body | After the administration of 177Lu-NRT6020, at least 7 days |
| Effective dose (stage 2 and stage 3) | Evaluate the dosimetry characteristics of 177Lu-NRT6020 Injection in the human body | After the administration of 177Lu-NRT6020, at least 7 days |
| Objective response rate (ORR) (stage 2 and stage 3) | Evaluated by the investigator in accordance with the RECIST v1.1/PERCIST criteria | After the administration of 177Lu-NRT6020, within 1 year |
| Duration of response (DOR) (stage 2 and stage 3) | Evaluated by the investigator in accordance with the RECIST v1.1/PERCIST criteria | After the administration of 177Lu-NRT6020, within 1 year |
| Progression-free survival (PFS) (stage 2 and stage 3) | Evaluated by the investigator in accordance with the RECIST v1.1/PERCIST criteria | After the administration of 177Lu-NRT6020, within 1 year |
| Radioactivity in biological specimen (stage 2) | Detect the radioactivity in specimen samples at various time points | After the administration of 177Lu-NRT6020, at least 7 days |
| Peak Plasma Concentration (Cmax) of 177Lu-NRT6020 (stage 2 and stage 3) | Multiple blood samples will be collected to determine the pharmacokinetic profiles of 68Ga-NRT6020 Injection | After the administration of 177Lu-NRT6020, at least 7 days |
| Time to reach maximum concentration (Tmax) of 177Lu-NRT6020 (stage 2 and stage 3) | Multiple blood samples will be collected to determine the pharmacokinetic profiles of 68Ga-NRT6020 Injection | After the administration of 177Lu-NRT6020, at least 7 days |
| Area under the plasma concentration versus time curve (AUC) of 177Lu-NRT6020 (stage 2 and stage 3) | Multiple blood samples will be collected to determine the pharmacokinetic profiles of 68Ga-NRT6020 Injection | After the administration of 177Lu-NRT6020, at least 7 days |
| Half life (t1/2) of 177Lu-NRT6020 (stage 2 and stage 3) | Multiple blood samples will be collected to determine the pharmacokinetic profiles of 68Ga-NRT6020 Injection | After the administration of 177Lu-NRT6020, at least 7 days |
| Objective response rate (ORR) (stage 3) | Evaluated by the Independent Review Committee (IRC) in accordance with the RECIST v1.1/PERCIST criteria | After the administration of 177Lu-NRT6020, within 1 year |
| Duration of response (DOR) (stage 3) | Evaluated by the Independent Review Committee (IRC) in accordance with the RECIST v1.1/PERCIST criteria | After the administration of 177Lu-NRT6020, within 1 year |
| Progression-free survival (PFS) (stage 3) | Evaluated by the Independent Review Committee (IRC) in accordance with the RECIST v1.1/PERCIST criteria | After the administration of 177Lu-NRT6020, within 1 year |
Compare the imaging parameter in different timepoints and different doses |
| After the administration of 68Ga-NRT6020, within 3 hours |
| Imaging dose of 68Ga-NRT6020 Injection (stage 3) | Compare the imaging parameter under different doses in order to select the optimal imaging dose | After the administration of 68Ga-NRT6020, within 3 hours |
| Scanning time window (stage 3) | Compare the imaging parameter in different timepoints and different doses | After the administration of 68Ga-NRT6020, within 3 hours |
| Tianjin Medical University Cancer Insititute & Hospital | Recruiting | Tianjin | China |
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