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177Lu-DOTA-TLX591 · 2 trials · 2 indications
The time from enrolment to time of PSA increase greater than 25%
To monitor the safety and tolerability of molecularly targeted radiotherapy with 177Lu-DOTA-TLX591, administered in two cycles in combination with best SoC in patients with PSMA-expressing metastatic castrate resistant prostate cancer. Treatment emergent adverse events (TEAE) will be classified according to MedDRA (Medical Dictionary for Regulatory Activities), frequency, severity according to NCI CTCAE V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE v.5.0.
| Arm | Type | Description |
|---|---|---|
| Single administration of 177Lu-DOTA-TLX591 | EXPERIMENTAL | Two single IV infusions of 76 mCi (2.8 GBq) each (equivalent to a 45 mCi/m2 administered activity in a standard 1.7m2 individual) of 177Lu-DOTA-TLX591, given 14 days apart. |
| Name | Type | Description |
|---|---|---|
| 177Lu-DOTA-TLX591 | BIOLOGICAL | TLX591, a monoclonal antibody conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591) |
Inclusion Criteria: * Signed Informed Consent Form * Male, aged ≥ 18 years * Estimated life expectancy of at least 6 months * Eastern Cooperative Oncology Group (ECOG) score 0 - 2 * Biopsy proven prostate adenocarcinoma with Gleason Score 7 or more at primary presentation * Previous Radical Prostat...
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177Lu-DOTA-TLX591 is an investigational radioligand therapy being studied for prostate cancer, including metastatic prostate cancer. It is being developed by Telix Pharmaceuticals Limited (ticker TLX) and has been evaluated in clinical trials in Australia in adult male patients aged 18 years and older.
177Lu-DOTA-TLX591 is a monoclonal antibody-based radioligand therapy. It combines the radioisotope lutetium-177 (177Lu) with the antibody TLX591, delivering radiation to target cells. The studies are biomarker-selected, meaning patients are chosen based on a specific biomarker, though the exact molecular target is not specified here.
177Lu-DOTA-TLX591 is being developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. Telix is an Australian-based biopharmaceutical company focused on oncology, and it is the sponsor of the clinical trials evaluating this radioligand therapy in prostate cancer.
177Lu-DOTA-TLX591 is in Phase 1 development. A Phase 1 safety, biodistribution and dosimetry study (NCT04786847) has been completed. A Phase 2 trial (NCT05146973) has also been completed. The drug remains investigational and is not approved for commercial use.
177Lu-DOTA-TLX591 has been studied in two completed clinical trials. NCT04786847 was a Phase 1 safety, biodistribution and dosimetry study in metastatic prostate cancer with 30 participants. NCT05146973 was a Phase 2 trial of external beam therapy with theranostic radioligand therapy in oligometastatic prostate cancer with 5 participants. Both were conducted in Australia.
177Lu-DOTA-TLX591 is not approved; it is an investigational therapy still in clinical development. It has completed a Phase 1 and a Phase 2 trial, but no regulatory approval has been granted. It is being developed by Telix Pharmaceuticals Limited (TLX) for prostate cancer.