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Radiopharmaceutical

177Lu-DOTA-FAPI dose escalation therapy study for Theranostics

Phase 1
Waitlist Available
Research Sponsored by The First Affiliated Hospital of Xiamen University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days from time of injection
Awards & highlights

Summary

This is a Phase I, first-in-human study to evaluate the safety and efficacy of the 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI theranostic pair in patients with various types of cancer (locally advanced or metastatic cancer).

Eligible Conditions
  • 177Lu-DOTA-TATE
  • Gallium-68 DOTA-FAPI
  • Theranostics

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days from time of injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days from time of injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
68Ga-DOTA-FAPI PET/CT imaging
[177Lu]Lu-DOTA-FAPI dose escalation therapy
Secondary study objectives
Assessment of organ dosimetry of 177Lu-DOTA-FAPI

Trial Design

2Treatment groups
Experimental Treatment
Group I: Recommended Phase 2 dose 177Lu-DOTA-FAPI therapy studyExperimental Treatment1 Intervention
Patients will be undergo 68Ga-DOTA-FAPI PET/CT scans to confirm eligibility for the 177Lu-DOTA-FAPI therapy. 10 patients will be enrolled in the dose expansion cohort and received the highest dose achieved in the 177Lu-DOTA-FAPI dose escalation therapy study
Group II: 177Lu-DOTA-FAPI dose escalation therapy studyExperimental Treatment1 Intervention
Patients will be undergo 68Ga-DOTA-FAPI PET/CT scans to confirm eligibility for the 177Lu-DOTA-FAPI therapy. Patients with sufficient lesion uptake of 68Ga DOTA-FAPI PET/CT will be offered therapy. Escalating doses of 30-150 mCi of 177Lu-DOTA-FAPI will be administered in a traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort.

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Who is running the clinical trial?

The First Affiliated Hospital of Xiamen UniversityLead Sponsor
130 Previous Clinical Trials
2,202,839 Total Patients Enrolled
Long Sun, PhDStudy ChairThe First Affiliated Hospital of Xiamen University
8 Previous Clinical Trials
461 Total Patients Enrolled
~7 spots leftby Sep 2025
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