Safety Trial of 68Ga/177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor Malignancy
• Intervention / Treatment: Diagnostic test: 68Ga-NRT6020 Injection; Drug: 177Lu-NRT6020 Injection (stage 2); Drug: 177Lu-NRT6020 Injection (stage 3)

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 Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xinxing Zhang; Phone Number: +8602867534532; Email: xinxing.zhang@nrtmedtech.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Principal Investigator: Jian Zhang
    • Principal Investigator: Shaoli Song
    • Contact: Shaoli Song; Phone Number: +86-021-34778299; Email: Shaoli-song@163.com
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University Cancer Insititute & Hospital
    • Principal Investigator: Dong Dai
    • Contact: Dong Dai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-NRT6020 Injection (stage 1); 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.	Diagnostic test: 68Ga-NRT6020 Injection; Participants will receive a single intravenous injection of 68Ga-NRT6020 Injection (3 mCi or 5 mCi) and PET/CT scans at multiple time points.
Experimental: 68Ga-NRT6020 Injection+ 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.	Diagnostic test: 68Ga-NRT6020 Injection; Participants will receive a single intravenous injection of 68Ga-NRT6020 Injection (3 mCi or 5 mCi) and PET/CT scans at multiple time points.; Drug: 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.
Experimental: 68Ga-NRT6020 Injection+ 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.	Diagnostic test: 68Ga-NRT6020 Injection; Participants will receive a single intravenous injection of 68Ga-NRT6020 Injection (3 mCi or 5 mCi) and PET/CT scans at multiple time points.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Chengdu New Radiomedicine Technology Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: solid tumor; FAP; Companion Diagnostics; Radionuclide Drug Conjugates
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: NRT6020-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No