PHASE III ProstACT GLOBAL STUDY
A multinational, multicenter, prospective, randomized, controlled, open label Phase III study designed to investigate and confirm the benefits and risks associated with the PSMA-targeted antibody, 177Lu DOTA rosopatamab administered together with Standard of Care (SoC), as compared to the best SoC alone. The phase III will be conducted in patients with metastatic castration-resistant PC (mCRPC) that expresses PSMA and has progressed despite prior treatment with a novel androgen axis drug (NAAD).
PHASE II ProstACT TARGET STUDY
A Phase II trial to evaluate the therapeutic efficacy of a radiolabelled PSMA-targeting antibody, 177Lu-TLX591, given in combination with external beam radiation therapy (EBRT) in patients with biochemically recurrent, oligometastatic, PSMA-expressing prostate cancer. TLX591 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radioisotope for the treatment of PSMA-expressing tumours.
PHASE I ProstACT SELECT STUDY
Trial of TLX591, a monoclonal antibody HuX591 conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591). TLX591 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radioisotope for the treatment of PSMA-expressing tumours, therefore this study has been designed to assess the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of 177Lu-DOTA-TLX591.
PHASE III ZIRCON STUDY
A confirmatory, prospective, open-label, multi-centre Phase III study to evaluate sensitivity and specificity of TLX250-CDx 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.
PHASE II STARLITE-1 STUDY
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.
PHASE II STARLITE-2 STUDY
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.
PHASE II STARBURST STUDY
A prospective, open-label, phase II study to explore CAIX expression through 89Zirconium-labelled girentuximab deferoxamine (89Zr-girentuximab) PET/CT imaging in patients with solid tumours.
PHASE I STARSTRUCK STUDY
An open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumours.
PHASE I/II IPAX-2 STUDY
An open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients.
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