Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AAA817 · 1 trial · 1 indication
Time to radiographic disease progression or death due to any cause.
| 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. |
| 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). |
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 small molecule being studied for the treatment of PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 3 clinical development and is being evaluated in combination with an androgen receptor pathway inhibitor (ARPI) versus standard of care in adult participants.
AAA817 is a small molecule that targets PSMA, a protein commonly expressed on prostate cancer cells. By targeting PSMA, AAA817 is designed to deliver treatment specifically to cancer cells. It is being studied in combination with an androgen receptor pathway inhibitor for PSMA-positive metastatic castration-resistant prostate cancer.
AAA817 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting a Phase 3 clinical trial to evaluate AAA817 in combination with an androgen receptor pathway inhibitor for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
AAA817 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is recruiting participants to study AAA817 in combination with an androgen receptor pathway inhibitor versus standard of care in adult patients with PSMA-positive metastatic castration-resistant prostate cancer.
AAA817 is being studied in a single Phase 3 clinical trial with the identifier NCT06855277. This randomized, active-controlled trial is recruiting 940 adult male participants with PSMA-positive metastatic castration-resistant prostate cancer across multiple countries, including the United States, Australia, Brazil, China, India, Japan, and the United Kingdom.