Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigators choice of SoC · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| Investigators choice of SoC | DRUG | The control treatment in Phase III is investigator's choice of SoC |
| AAA817 | DRUG | The investigational treatment is AAA817 |
Inclusion Criteria: ∙ * adults ≥ 18 years of age. * ECOG performance status of 0 to 2. * histopathological and/or cytological confirmation of adenocarcinoma of the prostate. * PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed, * castra...
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Investigators choice of SoC is a small molecule being studied for the treatment of prostate cancer, specifically in adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with and progressed on or after [177Lu]Lu-PSMA targeted therapy. It is currently in Phase 2 clinical development.
Investigators choice of SoC is being developed by Novartis AG, a global pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for the treatment of prostate cancer.
Investigators choice of SoC is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to evaluate the drug in patients with previously treated PSMA-positive metastatic castration-resistant prostate cancer.
Investigators choice of SoC is being evaluated in one active Phase 2 clinical trial with the identifier NCT06780670. This open-label, randomized, active-controlled study is comparing the drug against standard of care in adults with PSMA-positive mCRPC who have progressed on or after [177Lu]Lu-PSMA targeted therapy. The trial is recruiting participants across multiple countries.
Investigators choice of SoC is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied as a potential treatment option for patients with PSMA-positive metastatic castration-resistant prostate cancer who have previously received [177Lu]Lu-PSMA targeted therapy.
Investigators choice of SoC is the comparator arm in the clinical trial NCT06780670, which compares the investigational drug AAA817 against standard of care. The trial title refers to AAA817 as the study drug, while Investigators choice of SoC represents the control treatment. They are not the same intervention.