Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [225Ac]Ac-PSMA-617
AAA817 · 2 trials · 1 indication
Time to radiographic disease progression or death due to any cause.
Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement
Safety defined as the type, incidence and severity of AEs and SAEs, and deaths
Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure
Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis
Percentage of participants who are alive or who are lost to follow-up at the time of analysis
| Arm | Type | Description |
|---|---|---|
| Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone) | EXPERIMENTAL | Participants will receive AAA817 infusion directly into a vein with ARPIs. |
| Investigational Arm: AAA817 | EXPERIMENTAL | Participants will receive AAA817 infusion directly into a vein. |
| Control arm: Investigator's choice of SoC (ARPI or chemotherapy or AAA617) | ACTIVE_COMPARATOR | Participants will receive standard treatment as decided by the trial doctor either as a taxane-based chemotherapy infusion directly into a vein or ARPI change either as capsules or tablets or AAA617 monotherapy infusion directly into a vein. |
| Phase II: AAA817 Dose B | EXPERIMENTAL | AAA817 will be given for a number of cycles; a cycle = 8 weeks |
| Phase III: Investigator's choice of SoC | ACTIVE_COMPARATOR | Participants will be given Standard of Care (SOC) treatment per Investigator's choice. |
| Phase II: AAA817 Dose A | EXPERIMENTAL | AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks |
| Phase III: Recommended Phase 3 Dose of AAA817 | EXPERIMENTAL | Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks |
| Name | Type | Description |
|---|---|---|
| AAA817 | DRUG | AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them. This treatment is also called a radioligand therapy. |
| ARPI | DRUG | Androgen receptor pathway inhibitor (ARPI): An ARPI is approved for the treatment of prostate cancer. It works by blocking signals from male hormones, such as testosterone, that helps cancer cells grow. By blocking these signals, an ARPI slows down or stops the growth of prostate cancer cells. In this trial, participants will be given either enzalutamide or abiraterone. |
| Standard of Care | DRUG | Standard treatment includes approved treatment for mCRPC. In this trial, the trial doctor will decide which available treatment participants will receive. The trial doctor will select either an ARPI of enzalutamide or abiraterone, or a taxane based chemotherapy of docetaxel or cabazitaxel or \[177Lu\]Lu-PSMA-617 (AAA617). |
| Investigators choice of SoC | DRUG | The control treatment in Phase III is investigator's choice of SoC |
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Participants must be adults ≥ 18 years of age. * Participants must have an ECOG performance status of 0 to 2. * Participants must have histological, and/or cytological confirmation of adenocarc...
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AAA817 is an investigational therapy being developed for prostate cancer, specifically for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). It is being studied in adults whose disease has progressed, including patients previously treated with PSMA-targeted radioligand therapy. The trials enroll male participants aged 18 years and older.
AAA817 is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical trials evaluating AAA817 in prostate cancer.
AAA817 is in Phase 3 clinical development. It is also being evaluated in a Phase 2 trial. Both studies are currently recruiting participants. The Phase 3 trial is comparing AAA817 plus an ARPI against standard of care, while the Phase 2 trial is comparing AAA817 against standard of care in previously treated patients.
AAA817 is being studied in two active clinical trials. The Phase 3 trial, NCT06855277, is comparing AAA817 plus ARPI versus standard of care in adults with PSMA-positive mCRPC and has an enrollment target of 940 participants. The Phase 2 trial, NCT06780670, is comparing AAA817 versus standard of care in previously treated PSMA-positive mCRPC patients and has an enrollment target of 443 participants.
No, AAA817 is not approved by the FDA. It is an investigational drug still in clinical development, with Phase 3 and Phase 2 trials currently recruiting participants. The trials are evaluating its safety and efficacy in patients with PSMA-positive metastatic castration-resistant prostate cancer.