Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06
NCT07299253 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2025-12-23
Summary
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
- Metastatic Solid Tumors (Any Localization)
Interventions
- DRUG
-
radionuclide therapy with [177Lu]Lu--TEFAPI-06
A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics
Sponsors & Collaborators
-
Lanzhou University Second Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-16
- Primary Completion
- 2024-08-16
- Completion
- 2025-08-16
Countries
- China
Study Locations
More Related Trials
-
68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)
NCT04849247 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase II Clinical Study to Evaluate the Efficacy and Safety of Technetium [99mtc]-H7ND Injection in the Diagnosis of Peritoneal Metastasis of Gastrointestinal Malignant Tumor.
NCT07107633 ·Status: RECRUITING ·Phase: PHASE2
-
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
NCT06305962 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer
NCT06898437 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Study of TFX05-01 in Patients With Advanced Solid Tumors
NCT05434299 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Clinical Study of [225Ac]Ac-FAPI-XT(XT117) Injection in Patients With Advanced Solid Tumors
NCT07135128 ·Status: RECRUITING ·Phase: PHASE1
-
Application of 68Ga-NODAGA-SNA006 Positron Emission Tomography/Computed Tomography (PET/CT) in Tumors
NCT07059832 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors
NCT04843709 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma
NCT01667302 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
NCT07232407 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases
NCT07258147 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Phase I/II FIH Study of 9MW2921 in Patients With Advanced Solid Tumors
NCT05990452 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
NCT04952597 ·Status: COMPLETED ·Phase: PHASE2
-
Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
NCT06081686 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis
NCT04171986 ·Status: UNKNOWN ·Phase: NA
-
Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immunotherapy Era (Phase II)
NCT07320105 ·Status: RECRUITING ·Phase: PHASE4
-
Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)
NCT06217666 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Evaluation of 177Lu-TATE-EB-01(LNC1010)in SSTR2-positive Tumors
NCT05410743 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors
NCT06211647 ·Status: RECRUITING ·Phase: PHASE1
-
99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of PD-L1 Expression in NSCLC
NCT02978196 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
89Zr-labeled KN035 PET Imaging in Patients With PD-L1 Positive Solid Tumors
NCT04977128 ·Status: UNKNOWN ·Phase: NA
-
Technetium [99mTc]-H7ND in Patients With Gastrointestinal Malignancies and Healthy Volunteers
NCT06443710 ·Status: COMPLETED ·Phase: PHASE1
-
High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
NCT02284490 ·Status: UNKNOWN ·Phase: PHASE2
-
A Phase I Study of TAS-102 in Solid Tumors
NCT02261532 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
NCT06375564 ·Status: RECRUITING ·Phase: PHASE1