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Recruiting NCT06911489

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

Phase I Interventional Solid Tumor Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection (stage 2), 177Lu-NRT6020 Injection (stage 3).
Who it may be relevant to
Registry conditions: Solid Tumor Malignancy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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 S
  • 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.

Primary outcome measures

  • Adverse events [Time frame: Through study completion, an average of 1 year]
  • Dose-limiting toxicity (DLT) (stage 2) [Time frame: 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) [Time frame: Through study completion, an average of 1 year]
  • RP2D for 177Lu-NRT6020 Injection (stage 3) [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Fudan University Shanghai Cancer Center — Shanghai
  • Tianjin Medical University Cancer Insititute & Hospital — Tianjin

Identifiers

NCT: NCT06911489 · NRT6020-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗