Clinical trial NCT05963386: Clinical Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Various Solid Tumors
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Solid Tumor
Keywords: Refractory solid tumor
Radioligand therapy
177Lu-DOTA-EB-FAPI
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radiological response (according to RECIST criteria)
timeFrame: 6 weeks, 12 weeks, 18 weeks, or up to 6 months
Secondary outcomes:
measure: Progression-free survival (PFS) and overall survival (OS)
timeFrame: disease progression, death or last follow-up conducted for all patients at the end of August 2024.
measure: Dosimetry
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References: