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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 monoclonal antibody being studied for the treatment of prostate cancer, including metastatic prostate cancer. It is a radioligand therapy that delivers a radioactive payload to cancer cells. The drug is currently in clinical development and is not yet 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 stock is listed under the ticker symbol 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 remains 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 30 patients with metastatic prostate cancer in Australia. The second, NCT05146973, was a Phase 2 study of external beam therapy with theranostic radioligand therapy for oligometastatic prostate cancer.
177Lu-DOTA-TLX591 is a monoclonal antibody that targets prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. The antibody is linked to the radioactive isotope lutetium-177, which delivers targeted radiation to PSMA-expressing tumor cells, potentially damaging their DNA and causing cell death.
177Lu-DOTA-TLX591 is being evaluated in the ProstACT TARGET trial, which is a Phase 2 study. The drug itself is not referred to as ProstACT; ProstACT is the name of the clinical trial program. The investigational drug is identified by its chemical name, 177Lu-DOTA-TLX591.