Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 the treatment of prostate cancer. It is specifically being studied in adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The clinical program includes patients whose disease has progressed after prior treatment, including after [177Lu]Lu-PSMA targeted therapy.
AAA817 is being developed by Novartis AG, which trades 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. The Phase 3 trial is currently recruiting participants, and a Phase 2 trial is also ongoing. The drug remains investigational and has not been approved by the FDA for any indication.
AAA817 is being evaluated in two active clinical trials. NCT06855277 is a Phase 3 study comparing AAA817 plus an ARPI versus standard of care in adults with PSMA-positive mCRPC, with an enrollment of 940. NCT06780670 is a Phase 2 open-label study comparing AAA817 versus standard of care in previously treated PSMA-positive mCRPC patients who progressed on or after [177Lu]Lu-PSMA targeted therapy, with an enrollment of 443.
AAA817 targets PSMA, or prostate-specific membrane antigen. The clinical trials enroll patients with PSMA-positive metastatic castration-resistant prostate cancer, meaning their tumors express this target. PSMA is a protein commonly overexpressed on prostate cancer cells and is used as a biomarker to select patients for AAA817 therapy.