Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537596
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-29
Brief Title:
89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Phase 1 Study to Assess Safety Tolerability Dosimetry Pharmacokinetics and Imaging Properties of 89Zr-olaratumab 89Zr-TLX300-CDx in Participants With Soft Tissue Sarcoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZOLAR
Brief Summary:
Soft Tissue Sarcoma STS is a type of cancer that develops in soft tissues such as muscles tendons fat blood vessels and nerves STSs generally express a protein called Platelet-Derived Growth Factor Receptor PDGFRα which makes them a target for the development of STS therapies such as olaratumab
Olaratumab has been identified as a promising candidate to which radioactive substances can be attached for imaging or therapeutic purposes Thus this first in human imaging trial aims to study olaratumab combined with a radioactive metal called zirconium-89 89Zr-TLX300-CDx as a potential new product that may be used for STS imaging and identification of patients that may benefit from future treatments targeting PDGFRα
Olaratumab has been identified as a promising candidate to which radioactive substances can be attached for imaging or therapeutic purposes Thus this first in human imaging trial aims to study olaratumab combined with a radioactive metal called zirconium-89 89Zr-TLX300-CDx as a potential new product that may be used for STS imaging and identification of patients that may benefit from future treatments targeting PDGFRα
Detailed Description:
Platelet-derived growth factor receptor α PDGFRα is expressed on soft tissue sarcoma STS where it could act as a potential therapeutic target Olaratumab is a PDGFRα-targeted antibody that has the potential to act as the targeting moiety for both imaging and therapeutic radioisotopes Olaratumabs demonstrated safety profile and its ability to target PDGFRα on STS cell surfaces and be rapidly internalised make it a promising candidate for use as a radionuclide targeting agent in STS 89Zr-TLX300-CDx is being developed for PDGFRα molecular imaging with positron emission tomography PET in STS The aim of this study is to provide proof-of-concept tumour targeting of 89Zr-TLX300-CDx and assess the safety and radiation dosimetry of radiolabelled olaratumab This study will inform future development of olaratumab as a therapeutic radiopharmaceutical agent in STS
SCHEDULE OF ASSESSMENTS
Part A and B
IMAGING
1 single injection of 89Zr-TLX300-CDx on Day 1 and whole-body imaging at 6 days 1 day post-injection
Blood Collection for PHARMACOKINETICS
Pre-injection 4h 05h and 6 days 1 day post-injection
OPTIONAL
Imaging at 4h 05h post-injection
Part C
IMAGING
1 single injection of 89Zr-TLX300-CDx on Day 1 whole-body imaging at 24h 4h post-injection whole-body imaging at 4 days 1 post-injection and whole-body imaging at 7 days 1 day post-injection
Blood collection for PHARMACOKINECTCS
Pre-injection 4h 05h 24h 4h 4 days 1 day and 7 days 1 day post-injection
OPTIONAL
Dynamic imaging 15 min 2 min post-injection at selected sites extended field-of-view scanner is available imaging at 4h 05h post-injection and imaging at 7h 1hpost-injection
SCHEDULE OF ASSESSMENTS
Part A and B
IMAGING
1 single injection of 89Zr-TLX300-CDx on Day 1 and whole-body imaging at 6 days 1 day post-injection
Blood Collection for PHARMACOKINETICS
Pre-injection 4h 05h and 6 days 1 day post-injection
OPTIONAL
Imaging at 4h 05h post-injection
Part C
IMAGING
1 single injection of 89Zr-TLX300-CDx on Day 1 whole-body imaging at 24h 4h post-injection whole-body imaging at 4 days 1 post-injection and whole-body imaging at 7 days 1 day post-injection
Blood collection for PHARMACOKINECTCS
Pre-injection 4h 05h 24h 4h 4 days 1 day and 7 days 1 day post-injection
OPTIONAL
Dynamic imaging 15 min 2 min post-injection at selected sites extended field-of-view scanner is available imaging at 4h 05h post-injection and imaging at 7h 1hpost-injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None