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Clinical Trials in China / NCT06911489
Recruiting Phase 1

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

NCT06911489 · tracked via the Priya Life Science China tracker
Sponsor
Chengdu New Radiomedicine Technology Co. LTD
Phase
Phase 1
Started
2025-11-29
Last updated
2026-02-02

Condition(s) studied

Solid Tumor Malignancy

Investigational drug(s) / intervention(s)

68Ga-NRT6020 Injection177Lu-NRT6020 Injection (stage 2) →177Lu-NRT6020 Injection (stage 3) →

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.

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.

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.

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Adverse events — Through study completion, an average of 1 year
    Occurrence of adverse events
  • Dose-limiting toxicity (DLT) (stage 2) — 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) — 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) — Through study completion, an average of 1 year
    Determine the optimal dose of 177Lu-NRT6020

Trial sites (2)

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

More Chengdu New Radiomedicine Technology Co. LTD. trials in China

Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere Active, not recruiting
Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases Recruiting

Other trials for the same condition

A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients Recruiting
Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06911489 on ClinicalTrials.gov ↗ ← All trials in China