Clinical trial · Interventional
Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06
Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06: A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics
NCT07299253CI-TRIAL-00099549completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to systematically evaluate the safety, biodistribution, dosimetry, and preliminary therapeutic potential of \[177Lu\]Lu-TEFAPI-06 through an exploratory first-in-human (FIH) trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Solid Tumors (Any Localization) | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radionuclide therapy with [177Lu]Lu--TEFAPI-06 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with advanced metastatic solid tumors
- interventionNames
- Drug: radionuclide therapy with [177Lu]Lu--TEFAPI-06
Primary outcomes (1)
- measure
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
- timeFrame
- From Baseline up to 30 days after the last dose of study intervention (approximately 4 weeks)
- description
- Safety and tolerability will be assessed by recording the frequency, duration, and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs). The assessment includes clinically significant changes in vital signs (blood pressure, heart rate, respiratory rate, temperature), physical examination findings, 12-lead Electrocardiogram (ECG) parameters, and clinical laboratory tests (including Complete Blood Count \[CBC\], Urinalysis, Liver Function Tests \[LFTs\], and Renal Function Tests). Severity of adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Histologically confirmed advanced metastatic solid tumors refractory or intolerant to standard therapies * ECOG performance status 0-2 * Life expectancy \> 3 months * At least one FAP-avid lesion confirmed by baseline \[18F\]-FAPI PET/CT * Adequate organ and bone marrow function prior to the first dose Exclusion Criteria: * Chemotherapy, radiotherapy, or targeted therapy within 4 weeks * Severe hepatic or renal dysfunction * Uncontrolled active infection or severe comorbidities
References
Publications (0)
Data not yet available
No reference posted for this study.