Solid Tumor MalignancyPhase 1NCT06911489
Safety Trial of 68Ga/177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients
A Phase 1 study testing 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection (stage 2) and 177Lu-NRT6020 Injection (stage 3) in people with Solid Tumor Malignancy, run by Chengdu New Radiomedicine Technology Co. LTD. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor Malignancy
- What is being tested?
- 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection (stage 2) and 177Lu-NRT6020 Injection (stage 3)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesChina
- Study dates
- 29 Nov 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Participants must have adequate organ function;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥3 months;
- 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.
Who cannot join
- 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;
- Presence of severe or uncontrolled cardiac diseases requiring treatment;
- High risk of bleeding;
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- Active syphilis or human immunodeficiency virus (HIV) antibody positive;
- HBsAg-positive or HBcAb-positive with HBV-DNA levels above the detection limit;
- Failure to alleviate previous antitumor treatment toxicities to Grade 0 or 1 according to CTCAE v5.0;
- Participate in any other clinical trials within 1 month before the first dosing of 68Ga-NRT6020 Injection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Shaoli Song, +86-021-34778299, Shaoli-song@163.com
Shaoli Song
- Recruiting
Tianjin Medical University Cancer Insititute & Hospital
Tianjin
Dong Dai
Dong Dai
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of 68Ga-NRT6020 Injection and 177Lu-NRT6020 Injection in FAP-Positive Participants With Advanced Solid Tumors
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Solid Tumor Malignancy
- Being tested
- 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection (stage 2), 177Lu-NRT6020 Injection (stage 3)
- Keywords
- solid tumor, Radionuclide Drug Conjugates, Companion Diagnostics, FAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NRT6020 InjectionDiagnostic 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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 68Ga-NRT6020 Injection |
| 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. Receives: Diagnostic Test: 68Ga-NRT6020 Injection; Drug: 177Lu-NRT6020 Injection (stage 2) |
| 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. Receives: Diagnostic Test: 68Ga-NRT6020 Injection; Drug: 177Lu-NRT6020 Injection (stage 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Occurrence of adverse events
Measured: Through study completion, an average of 1 year
Dose-limiting toxicity (DLT) (stage 2)
Evaluate the safety and tolerability of 177Lu-NRT6020
Measured: 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
Measured: Through study completion, an average of 1 year
RP2D for 177Lu-NRT6020 Injection (stage 3)
Determine the optimal dose of 177Lu-NRT6020
Measured: Through study completion, an average of 1 year
Secondary outcomes (23)
Standardized uptake values (SUV) (stage 1)
Evaluate the distribution of 68Ga-NRT6020 Injection in various tissues and organs of the human body
Measured: After the administration of 68Ga-NRT6020, within 24 hours
Absorbed dose (stage 1)
Evaluate the dosimetry characteristics of 68Ga-NRT6020 Injection in various tissues and organs of the human body
Measured: 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
Measured: After the administration of 68Ga-NRT6020, within 24 hours
Scanning time window (stage 1)
Compare the imaging parameter in different timepoints and different doses
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After the administration of 177Lu-NRT6020, within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start29 Nov 2025
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu New Radiomedicine Technology Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911489
- Sponsor's protocol ID
- NRT6020-101
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of 68Ga-NRT6020 Injection and 177Lu-NRT6020 Injection in FAP-Positive Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06911489
- Acronym / sponsor ID
- NRT6020-101
- Conditions
- Solid Tumor Malignancy
- Keywords
- solid tumor, Radionuclide Drug Conjugates, Companion Diagnostics, FAP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Chengdu New Radiomedicine Technology Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NRT6020 Injection (stage 1) | Experimental | Diagnostic Test: 68Ga-NRT6020 InjectionStage 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. |
| 68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 2) | Experimental | Diagnostic Test: 68Ga-NRT6020 Injection, Drug: 177Lu-NRT6020 Injection (stage 2)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. |
| 68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 3) | Experimental | Diagnostic Test: 68Ga-NRT6020 Injection, Drug: 177Lu-NRT6020 Injection (stage 3)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- Participants must have adequate organ function;
Key exclusion criteria (10 listed)
- 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;
- Presence of severe or uncontrolled cardiac diseases requiring treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NRT6020 InjectionParticipants will receive a single intravenous injection of 68Ga-NRT6020 Injection (3 mCi or 5 mCi) and PET/CT scans at multiple time points. | Diagnostic test | 68Ga-NRT6020 Injection (stage 1), 68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 2), 68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 3) |
| 177Lu-NRT6020 Injection (stage 2)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. | Drug | 68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 2) |
| 177Lu-NRT6020 Injection (stage 3)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. | Drug | 68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 3) |
Primary outcome
Adverse events
Time frame: Through study completion, an average of 1 year
Occurrence of adverse events
Dose-limiting toxicity (DLT) (stage 2)
Time frame: After the first dose of 177Lu-NRT6020 administration, up to 42 days
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)
Time frame: Through study completion, an average of 1 year
Evaluating the safety and tolerability of 177Lu-NRT6020 with the aim of determining the optimal dose
RP2D for 177Lu-NRT6020 Injection (stage 3)
Time frame: Through study completion, an average of 1 year
Determine the optimal dose of 177Lu-NRT6020
23 secondary outcomes
Standardized uptake values (SUV) (stage 1)
Time frame: After the administration of 68Ga-NRT6020, within 24 hours
Absorbed dose (stage 1)
Time frame: After the administration of 68Ga-NRT6020, within 24 hours
Effective dose (stage 1)
Time frame: After the administration of 68Ga-NRT6020, within 24 hours
Scanning time window (stage 1)
Time frame: After the administration of 68Ga-NRT6020, within 3 hours
Radioactivity in biological specimen (stage 1)
Time frame: After the administration of 68Ga-NRT6020, within 24 hours
Peak Plasma Concentration (Cmax) of 68Ga-NRT6020 (stage 1)
Time frame: After the administration of 68Ga-NRT6020, within 24 hours
Time to reach maximum concentration (Tmax) of 68Ga-NRT6020 (stage 1)
Time frame: After the administration of 68Ga-NRT6020, within 24 hours
Area under the plasma concentration versus time curve (AUC) of 68Ga-NRT6020 Injection (stage 1)
Time frame: After the administration of 68Ga-NRT6020, within 24 hours
Half life (t1/2) of 68Ga-NRT6020 (stage 1)
Time frame: After the administration of 68Ga-NRT6020, within 24 hours
Standardized uptake values (SUV) (stage 2 and stage 3)
Time frame: After the administration of 177Lu-NRT6020, at least 7 days
Absorbed dose (stage 2 and stage 3)
Time frame: After the administration of 177Lu-NRT6020, at least 7 days
Effective dose (stage 2 and stage 3)
Time frame: After the administration of 177Lu-NRT6020, at least 7 days
Objective response rate (ORR) (stage 2 and stage 3)
Time frame: After the administration of 177Lu-NRT6020, within 1 year
Duration of response (DOR) (stage 2 and stage 3)
Time frame: After the administration of 177Lu-NRT6020, within 1 year
Progression-free survival (PFS) (stage 2 and stage 3)
Time frame: After the administration of 177Lu-NRT6020, within 1 year
Radioactivity in biological specimen (stage 2)
Time frame: After the administration of 177Lu-NRT6020, at least 7 days
Peak Plasma Concentration (Cmax) of 177Lu-NRT6020 (stage 2 and stage 3)
Time frame: After the administration of 177Lu-NRT6020, at least 7 days
Time to reach maximum concentration (Tmax) of 177Lu-NRT6020 (stage 2 and stage 3)
Time frame: 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)
Time frame: After the administration of 177Lu-NRT6020, at least 7 days
Half life (t1/2) of 177Lu-NRT6020 (stage 2 and stage 3)
Time frame: After the administration of 177Lu-NRT6020, at least 7 days
Objective response rate (ORR) (stage 3)
Time frame: After the administration of 177Lu-NRT6020, within 1 year
Duration of response (DOR) (stage 3)
Time frame: After the administration of 177Lu-NRT6020, within 1 year
Progression-free survival (PFS) (stage 3)
Time frame: After the administration of 177Lu-NRT6020, within 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection (stage 2) and 177Lu-NRT6020 Injection (stage 3) in people with Solid Tumor Malignancy, run by Chengdu New Radiomedicine Technology Co. LTD. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinxing Zhang (+8602867534532, xinxing.zhang@nrtmedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.