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

NCT06911489 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NRT6020-101
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Tumor Malignancy

Keywords

solid tumor; Radionuclide Drug Conjugates; Companion Diagnostics; FAP

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (23)

• Standardized uptake values (SUV) (stage 1)

  After the administration of 68Ga-NRT6020, within 24 hours

• Absorbed dose (stage 1)

  After the administration of 68Ga-NRT6020, within 24 hours

• Effective dose (stage 1)

  After the administration of 68Ga-NRT6020, within 24 hours

• Scanning time window (stage 1)

  After the administration of 68Ga-NRT6020, within 3 hours

• Radioactivity in biological specimen (stage 1)

  After the administration of 68Ga-NRT6020, within 24 hours

Other Outcomes (4)

• Consistency of 68Ga-NRT6020 Injection PET/CT imaging

  After the administration of 68Ga-NRT6020, within 3 hours

• Scanning time window (stage 2)

  After the administration of 68Ga-NRT6020, within 3 hours

• Imaging dose of 68Ga-NRT6020 Injection (stage 3)

  After the administration of 68Ga-NRT6020, within 3 hours

Study Arms (3)

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.

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.

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.

Diagnostic Test: 68Ga-NRT6020 Injection; Drug: 177Lu-NRT6020 Injection (stage 3)

Interventions

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.

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) 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.

68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 2)

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.

68Ga-NRT6020 Injection+ 177Lu-NRT6020 Injection (stage 3)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Chengdu New Radiomedicine Technology Co. LTD.: lead

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, China

RECRUITING

Central Study Contacts

Xinxing Zhang

CONTACT

+8602867534532; xinxing.zhang@nrtmedtech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 4, 2025
• Study Start: November 29, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)