Brief Summary
Soft Tissuetissue/the material that joins, holds up or surrounds inside body parts such as fat, muscle, ligaments and lining around joints Sarcomacancer arising from bones and/or soft tissue (STS) is a type of cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs that develops in soft tissues such as muscles, tendonsa type of connective tissue that connects muscle to bone, fat, bloodthe red bodily fluid that transports oxygen and other nutrients around the body vessels, and nerves. STSs generally express a protein called Platelet-Derived Growth Factor Receptor (PDGFR)α, 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 imagingtests that create detailed images of areas inside the body 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.
Intervention / Treatment
- Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
Inclusion Criteria
- ≥18 years of age at the time of signing the informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
- Histologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of soft tissuea group of cells that work together to perform a function sarcoma (STS)
- At least one massa growth of cells that come together to make a lump, may or may not be cancer of > 2 cm in largest diameter seen on standard of care imaging (CT, MRI and/or FDG-PET).
- For Part A: Participants must have tumoura tissue mass that forms from groups of unhealthy cells PDGFRα expression confirmed by IHC. Participants must have consented to provide archived FFPE tumour tissue or be subject to a biopsyremoval of a section of tissue to analyse for cancer cells of the target tumour (if archived tissue is unavailable).
For Parts B and C: all participants will be included regardless of their PDGFRα expression status on archival tissue/biopsy (unless otherwise specified). Participants must have consented to provide available archived FFPE tumour tissue.
- Adequate haematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500/ μL, haemoglobin ≥ 9.0 g/dL, and a platelet count of 100,000/μL obtained.
- Adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN).
- Adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the participant’s creatinine clearance is ≥ 45 mL/min.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 to 2.
- Life expectancy of at least 6 months.
- Female participants of childbearing potential must have negative pregnancy tests at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening, as well as confirmation of negative pregnancy test result within 24 hours prior to receiving 89Zr-TLX300-CDx. Female participants of childbearing potential or male participants with female partners of childbearing potential must:
- be willing to practice full and true sexual abstinence; or
- be surgically/permanently sterile or with a history of hysterectomycomplete or partial removal of the uterus for women; or
- be willing to practice highly effective contraception by using: a non-oral, injected or implanted non-oestrogen progesterone based hormonal method, male condom, vaginal diaphragm, cervical cap, intrauterine device, for 3 months after the administration of 89Zr-TLX300-CDx.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.