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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 the treatment of prostate cancer, including metastatic prostate cancer. It is a monoclonal antibody-based therapy developed by Telix Pharmaceuticals. As of now, it is in clinical development and has not been approved by regulatory authorities.
177Lu-DOTA-TLX591 is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company. Telix is focused on the development of diagnostic and therapeutic radiopharmaceuticals. The company's ticker symbol is TLX.
177Lu-DOTA-TLX591 is in Phase 1 clinical development. A Phase 1 study has been completed, and a Phase 2 study has also been completed. The drug is investigational and has not received regulatory approval for any indication.
177Lu-DOTA-TLX591 has been studied in two clinical trials. The first, NCT04786847, was a Phase 1 safety, biodistribution, and dosimetry study in patients with metastatic prostate cancer. The second, NCT05146973, was a Phase 2 study combining external beam therapy with radioligand therapy for oligometastatic prostate cancer.
177Lu-DOTA-TLX591 is a radioligand therapy that combines a monoclonal antibody with the radioactive isotope lutetium-177. The antibody component is designed to target prostate-specific membrane antigen (PSMA), which is expressed on prostate cancer cells, delivering radiation directly to the tumor.