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NCT Number: NCT05963386

Clinical Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Various Solid Tumors

Increased fibroblast activation protein expression is positively correlated with the aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with refractory cancer and disease progression after multiple-lines treatment. However, a major problem in the therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance. This study was designed to investigate the efficacy and safety of 177Lu-DOTA-EB-FAPI in patients with various solid tumors who had failed standard therapies.

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Key information

Conditions

Refractory Solid Tumor

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

About this study

This investigator-initiated phase II study will include a maximum of 30 subjects with progressive cancer after multiple-line treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46 PET/CT. The fixed dose of 177Lu-DOTA-EB-FAPI is 3.3GBq (90 mCi) per cycle. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the radiological response (according to RECIST criteria) after completion of radioligand therapy. The secondary endpoints included progression-free survival (PFS), overall survival (OS), dosimetry, and safety of 177Lu-DOTA-EB-FAPI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to understand and willingness to sign a written informed consent document.
  • Age 18 and older.
  • Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis).
  • Progressive disease after multiple-lines treatment.
  • Completion of entry into 68Ga-FAPI-46 study and completion of scan. The tumor lesions showing increased radiotracer uptake on 68Ga-FAPI-46 PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of metastatic lesions).
  • Able to remain motionless for up to 30-60 minutes per scan.

Exclusion criteria

  • Serum creatinine level >150 μmol/L.
  • Hemoglobin level <8.0 g/dL; white-cell count < 2.0×109/L; platelet count < 50×109/L; total bilirubin level >3 times the upper limit of the normal range and serum albumin level <2.0 g/dL.
  • Participants with Class 3 or 4 NYHA Congestive Heart Failure.
  • Participants with severe allergy, or hypersensitivity to radiographic contrast material.
  • Participants with claustrophobia.
  • Pregnant or lactating women.

Treatment and study plan

177Lu-DOTA-EB-FAPI radionuclide therapy

Drug

radionuclide therapy using 177Lu-DOTA-EB-FAPI 90 mCi (3.3 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.

Primary outcomes

  1. Radiological response (according to RECIST criteria)

    Time frame: 6 weeks, 12 weeks, 18 weeks, or up to 6 months

    RECIST objective response after completion of radioligand therapy, which was defined by response category between baseline and restaging after RLT. Disease control after RLT was defined as either complete response (CR), partial response (PR), or stable disease (SD). Disease control rate (DCR) was reported as the proportion of patients with disease control after RLT.

Secondary outcomes

  1. Progression-free survival (PFS) and overall survival (OS)

    Time frame: disease progression, death or last follow-up conducted for all patients at the end of August 2024.

    PFS was recorded from start of RLT until RECIST progression, death, or last follow-up. OS was recorded from start of RLT until death or last follow-up conducted for all patients at the end of August 2024.

  2. Dosimetry

    Time frame: 6 weeks

    Dosimetry, measured as the absorbed dose in tumors (Gy/GBq), was estimated in the first treatment cycle for each patient.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

An Open-Label, Non-Randomized, Single-Center, Investigator-initiated Phase II Trial to Determine the Efficacy and Safety of 177Lu-DOTA-EB-FAPI in Patients With Various End-stage Solid Tumors

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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