AvidinOX + [177Lu]DOTA-biotin (or 177Lu-ST2210) Complex in Patients With Liver Metastases From Colorectal Cancer

Liver Metastases Clinical Trial

Official title:
A Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Dosimetry, Maximum Tolerated Dose and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by Systemic IV Administration of Escalating Doses of [177Lu]DOTA-biotin in Patients With Liver Metastases From Colorectal Cancer

Status Terminated

Clinical Trial Summary

The purpose of the study is to assess a new treatment for patients with liver tumor metastases from colorectal cancer. The treatment has never been used in humans before. The treatment foresees the use of two compounds: AvdinOX and [177Lu]DOTA-biotin.

AvidinOX is a new compound, essentially a natural protein obtained from hen eggs, while [177Lu]DOTA-biotin is a new chemical compound resulting from the combination of the DOTA-biotin (also deriving from a natural vitamin which is biotin) with the 177Lutetium, an atom which emits radiation.

AvidinOX will be injected directly into the metastases in the liver and [177Lu]DOTA-biotin will be injected into the arm vein.

One specific property of AvidinOX is that it chemically links to the tumor tissues when it is injected while maintaining the capacity to take up [177Lu]DOTA-biotin. Once locally bound in tumor tissue, AvidinOX becomes an "artificial receptor" for intravenously injected [177Lu]DOTA-biotin, which allows an internal radiation therapy of the tumor tissue.

The treatment of liver metastases with local injection of AvidinOX and the following intra-venous injection of [177Lu]DOTA-biotin could be simpler and more tolerable than the current available treatments.

Clinical Trial Description

Primary objectives

1. To identify the Maximum Tolerated Dose (MTD) of 177Lu-ST2210 after prior intra-lesional injection of AvidinOX in the liver.

2. To assess safety and tolerability of intra-lesionally injected AvidinOX + IV injected 177Lu-ST2210

3. To evaluate intra-lesional distribution and retention of AvidinOX + 177Lu-ST2210 complex in liver metastases

4. To evaluate systemic biodistribution and pharmacokinetics of 177Lu-ST2210 and {AvidinOX + 177Lu-ST2210}- complex

Secondary objectives

1. To evaluate proportional 177Lu-ST2210 tumor binding, as a function of total tumor load, and AvidinOX dose injected

2. To demonstrate AvidinOX post-deposition reactivity with 177Lu-ST2210 over time

3. To evaluate whole body dosimetry of IV 177Lu-ST2210 after prior AvidinOX injection (radiation safety dosimetry)

4. To record individual tumor dosimetry

5. To evaluate preliminary efficacy of {AvidinOX + 177Lu-ST2210}-complex in reducing tumor size

6. To evaluate whole body safety dosimetry and dose linearity of IV administered 177Lu-ST2210 after prior intra-lesional injection of AvidinOX

7. To evaluate pharmacokinetics of ST2210 in plasma and urine ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02053324
Study type	Interventional
Source	Alfasigma S.p.A.
Contact
Status	Terminated
Phase	Phase 1
Start date	November 11, 2013
Completion date	July 1, 2019

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03781934` - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations	Phase 1/Phase 2
Completed	`NCT02107755` - Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma	Phase 2
Recruiting	`NCT05057052` - Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis	Phase 2
Recruiting	`NCT06120127` - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence	Phase 2
Recruiting	`NCT04837885` - Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases	Phase 2
Terminated	`NCT04589884` - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Not yet recruiting	`NCT04520737` - Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases	N/A
Terminated	`NCT02465112` - Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor	Phase 3
Completed	`NCT02352259` - Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II	Phase 2
Active, not recruiting	`NCT01763450` - Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer	Phase 2
Withdrawn	`NCT01631539` - Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC	N/A
Recruiting	`NCT01250158` - Liver-PILP First-in-Man	N/A
Terminated	`NCT01233544` - Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases	Phase 3
Completed	`NCT01347333` - Stereotactic Body Radiotherapy for Liver Tumors	N/A
Completed	`NCT00587756` - Alternative to Two-Stage Hepatectomy	N/A
Completed	`NCT01683357` - Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases	N/A
Completed	`NCT04942665` - Low Dose ICG for Biliary Tract and Tumor Imaging	Phase 2
Not yet recruiting	`NCT05354674` - Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
Recruiting	`NCT04616495` - Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Not yet recruiting	`NCT04509635` - Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis	Phase 3