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RecruitingNCT06632873Updated Oct 15, 2024

177Lu-TATE-RGD in Patients With SSTR2 and Integrin αVβ3 Positive Tumors

An Early Phase 1 interventional study of 177Lu-TATE-RGD in SSTR2 and Integrin αVβ3 Positive Tumors, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Researchers has conducted extensive research on the treatment of neuroendocrine tumors with 177Lu-EB-TATE and the treatment of FAP-expressing tumors with 177Lu-EB-FAPI, and some researches have revealed 68Ga-TATE-RGD in imaging studies of neuroendocrine tumors to find that the dual-targeted tracer showed an increasing TBR, suggesting the tracer kinetic advantage of TATE-RGD; compared to the single-target tracer DOTATATE, the dual-target TATE-RGD probe has a clear advantage in detecting liver metastases of NETs, and it can be explored for potential therapeutic uses of TATE-RGD in future studies and used for related companion diagnostics in targeted radioisotope therapy (RLT).

Read the detailed description

Integrin αvβ3 is highly expressed in certain tumor cells and newly formed blood vessels, making it an ideal target for diagnosis and treatment of integrin αVβ3 positive tumors. 177Lu-TATE-RGD is a novel drug developed independently in China, providing an effective target for the treatment of integrin αVβ3 positive tumors. All patients underwent whole-body 68Ga-TATE-RGD PET/CT screening within one week and received a single intravenous injection of 1.48-3.33 GBq (40-100 mCi) 177Lu-TATE-RGD within one week. Blood samples were collected from the vein in 1-2 mL volumes at 5 minutes, 3 hours, 24 hours, 72 hours, and 168 hours after injection to measure radioactivity. Then, whole-body planar and SPECT/CT imaging was performed at 3, 24, 48, 72, 96, 120, and 168 hours after the injection of 177Lu-TATE-RGD. The in vivo radiation dose of 177Lu-TATE-RGD was analyzed and calculated, and the therapeutic effect and response were evaluated.

02

Conditions studied

  • SSTR2 and Integrin αVβ3 Positive Tumors
03

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with clear pathological diagnosis and ineffective or progressing clinical conventional treatment;
  • tumor lesions with high SSTR2 and RGD untake confirmed on 68Ga-TATE-RGD PET/CT within one week before the injection of 177Lu-TATE-RGD;
  • signed written consent.

Exclusion criteria

Exclusion Criteria:

  • the exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    1.48-3.33 GBq of 177Lu-TATE-RGD

    The patients were intravenously injected with the dose about 1.48-3.33 GBq(60-100m Ci) 177Lu-TATE-RGD and underwent 68Ga-TATE-RGD PET/CT scans before and after the treatment.

    Drug: 177Lu-TATE-RGD

Interventions

  • Drug177Lu-TATE-RGD

    accepted intravenous injection of 177Lu-TATE-RGD

06

What researchers measure

Primary outcomes

  1. StandarStandardized uptake value of 177Lu-TATE-RGD in normal organs and tumors.

    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and tumors will be measured.

    Time frame: through study completion, an average of half-year

Secondary outcomes

  1. Adverse events collection

    Adverse events within 2 months after the injection and scanning of patients will be followed and assessed.

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Chinese Academy of Medical Science & Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06632873
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Zhaohui Zhu (Clinical Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Oct 9, 2024
Start date
Sep 1, 2024
Primary completion
Jan 30, 2025 (estimated)
Completion
Feb 20, 2025 (estimated)
Last update
Oct 15, 2024

Study contacts

Zhaohui Zhu, MD
Contact
13611093752@163.com
13611093752

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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