Our Pipeline

Kidney/CA9

Renal cell carcinoma (RCC) is the most common form of kidney cancer. RCC is an increasingly frequent cancer, having more than doubled in incidence in the developed world over the last 50 years (Padala et al, World Journal of Oncology, 2020). Worldwide, there were more than ~400,000 new cases in 2020, and >175,000 people died from their disease (WHO, 2020).

Carbonic Anhydrase IX (CA9) is a cell-surface antigen and a cancer target that is overexpressed in renal cancer and a number of other cancers including bladder or urothelial, breast, brain, cervix, colon, oesophagus, head and neck, lung, ovarian, pancreatic and vulval.

Telix is investigating CA9 as a potential target for renal cancer theranostics and in other tumour types that are known to overexpress CA9.

For more information on Telix’s clinical trials in renal cancer please see trial descriptions below, clickable through to clinical trial database where registered:

Imaging

ZIRCON
A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate sensitivity and specificity of TLX250 (89Zr-TLX250) Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with indeterminate renal masses (IRM), scheduled for partial or total nephrectomy.

ZIRDAC JP
Phase I / Phase II (ZIRDAC-JP) Phase I/II study to be conducted in Japan to look at safety and tolerability, as well as dosimetry of 89Zr-TLX250 in the Japanese population. Phase II study is designed to evaluate at the diagnostic performance of 89Zr-TLX250 in detecting ccRCC by PET/CT imaging in patients with an indeterminate renal mass

ZIRDOSE
A Phase I bridging study using 89Zr-TLX250 to image ccRCC. The trial was designed to evaluate dosimetry and image quality between 5mg versus 10mg mass doses of TLX250 radiolabelled with 37MBq of 89Zr

Therapy

STARLITE-1
A Phase Ib/II combination study with 177Lu-TLX250 with duo of pembrolizumab+axitinib in front line metastatic ccRCC. Study endpoint in Phase 1b will be the maximal tolerated dose of 177Lu-TLX250 in combination with pembrolizumab+axitinib combination. Study endpoint in Phase II will be complete response rate with the combination therapy.

STARLITE-2
A Phase II trial evaluating the combination therapy of 177Lu-TLX250 with ipilimumab+nivolumab in metastatic ccRCC patients who have progressed on initial checkpoint inhibitor or TKI therapy. Endpoints include safety and tolerability and objective response rate with this combination.

Different Tumour Types

Zip-UP
Zirconium-girentuximab PET in Urothelial Cancer Patients

OPALESCENCE
Prospective Phase II Pilot Study, Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT (Positron Emission Tomography/Computerized Tomography) in Metastatic Triple Negative Breast Cancer Patients

PERTINENCE
Assessment of safety, tolerability, radiation dosimetry, and imaging properties of 89Zr-labeled girentuximab (89Zr-Girentuximab) in patients with non-muscle-invasive bladder cancer (NMIBC)

Prostate/PSMA

Prostate cancer is the most commonly diagnosed male cancer and a leading cause of death in men. Worldwide. In 2020 more than 1.4 million men were diagnosed, and >375,000 died from their disease (WHO, 2020).

Prostate-specific membrane antigen (PSMA) is a transmembrane protein expressed on many neoplastic and intrinsic tissues. PSMA is highly expressed on prostate epithelial cells and strongly upregulated in prostate cancer and, particularly, advanced prostate cancer.

Telix is investigating PSMA as a potential target for prostate cancer theranostics.

For more information on Telix’s clinical trials in prostate cancer please see trial descriptions below, clickable through to clinical trial database where registered:

Imaging

University of Linz  TLX591-CDx

Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes –
Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes

ENHANCING
Exploring the role of androgen receptor blockade in increasing the expression of prostate specific membrane antigen (PSMA) and enhancing TLX591 (68Ga-PSMA-11-PET/CT) imaging in patients with metastatic prostate cancer.

Memorial Sloan Kettering

NOBLE Registry

A global consortium of 7 investigator-led studies collecting prospective, real-world clinical data on the use of TLX599-CDx. The objective is to generate a data repository – which may inform further development of PSMA-SPECT products for emerging markets.

Therapy

ProstACT
A Multinational, Multicenter, Prospective, Randomized, Controlled, Open Label Phase 3 Study With Best Standard of Care With and Without TLX591 (177Lu-DOTA-rosopatamab) for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment With a Novel Androgen Axis Drug.

CUPID
A Phase I, Single Centre, Open-label Study of TLX592 to Assess the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry in Patients Diagnosed With Prostate Cancer.

Different Tumour Types

Emory University TLX591-CDx in lobular breast cancer

Brain/LAT-1

Glioblastoma (GBM) is the most common and aggressive form of primary brain cancer. Worldwide, more than 300,000 people were diagnosed with brain or central nervous system cancer in 2020, and 250,000 died from their disease (WHO, 2020).

The mainstay of treatment for GBM typically comprises surgical resection, followed by combined radiotherapy and chemotherapy. 

However, despite such treatment, most patients experience recurrence of their GBM, with an expected survival duration of approximately 15 months from diagnosis (Fernandes et al, Current Standards of Care in Glioblastoma Therapy, 2017).

L-type amino acid transporter 1 (LAT-1) is a heterodimeric membrane transport protein that is typically highly expressed in GBM.

Telix is investigating LAT-1 as a potential target for GBM theranostics.

For more information on Telix’s clinical trials in brain cancer please see trial descriptions below, clickable through to clinical trial database where registered:

Therapy

IPAX-1
A Multi-centre, Open-label, Single-arm, Dose-finding Phase I/II Study to Evaluate Safety, Tolerability, Dosing Schedule, and Preliminary Efficacy of TLX101 (Carrier-added 4-L-[131I]Iodo-phenylalanine (131I-IPA)), Administered as Single or Repetitive Injections in Patients With Recurrent Glioblastoma Multiforme (GBM), Concomitantly to 2nd Line External Radiation Therapy (XRT) – IPAX-1

IPAX-2
Coming soon

Rare disease and Bone marrow Conditioning/CD66

The indications for bone marrow transplantation are increasing from haematological malignancies to solid tumours and autoimmune conditions.

Traditional conditioning regimens are associated with morbidity and mortality from chemotherapy, limiting their use particularly in paediatric and rare diseases.

CD66 is a receptor expressed on granulocytes and a potential target for novel conditioning radiopharmaceuticals and has been granted orphan drug designation (ODD) status in Europe for bone marrow conditioning for hematopoietic stem cell transplantation (HSCT), a broad clinical indication.

For more information on Telix’s clinical trials in rare disease and bone marrow conditioning please see trial descriptions below, clickable through to clinical trial database where registered:

Therapy

TRALA
A Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis