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

NCT05963386 | Completed Phase 2

• 1 other identifier: XMFHIIT-2023KY037
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Solid Tumor

Keywords

Refractory solid tumor; Radioligand therapy; 177Lu-DOTA-EB-FAPI

Outcome Measures

Primary Outcomes (1)

• Radiological response (according to RECIST criteria)

  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.

  6 weeks, 12 weeks, 18 weeks, or up to 6 months

Secondary Outcomes (2)

• Progression-free survival (PFS) and overall survival (OS)

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

• Dosimetry

  6 weeks

Study Arms (1)

177Lu-DOTA-EB-FAPI

EXPERIMENTAL

177Lu-DOTA-EB-FAPI A maximum of 4 cycles of 90 mCi (3.3 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, every 6 weeks

Drug: 177Lu-DOTA-EB-FAPI radionuclide therapy

Interventions

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.

177Lu-DOTA-EB-FAPI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: February 22, 2022
• Primary Completion: September 15, 2024
• Study Completion: October 5, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)