Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMO959 · 1 trial · 1 indication
Incidence of dose limiting toxicities (DLTs) with AMO959 in combination with AAA617 +/- ARPI A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the evaluation period and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading.
Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation).
Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity).
Duration of exposure (in months) to each study drug.
Biochemical response (PSA50), defined as the proportion of participants who achieved a ≥ 50% decrease in PSA from baseline at any time during the treatment period prior to start of new anti-cancer therapy that is confirmed by a second PSA measurement ≥ 4 weeks later.
| Arm | Type | Description |
|---|---|---|
| Phase 1b: Doublet | EXPERIMENTAL | Participants will receive AMO959 BID for first 14 days followed by AAA617+AMO959 every 6 weeks for a maximum of 6 cycles. |
| Phase 1b: Triplet | EXPERIMENTAL | Participants will receive AAA617 on day 1 followed by AMO959 BID (days 2-15), repeated every 6 weeks, for a maximum of 6 cycles with an ARPI (abiraterone or enzalutamide) administered continuously starting on day 1. |
| Phase 1b: Food Effect | EXPERIMENTAL | Participants will receive a single dose of AMO959 on Day 1 (fed), followed by 2-day washout, then AMO959 BID (fasted) for 14 days followed by 2-day washout and AAA617+AMO959 (fasted) every 6 weeks for a maximum of 6 cycles. |
| Phase II: Arm 1 | EXPERIMENTAL | Participants will receive AAA617 on day 1 followed by AMO959 BID (days 2-15), repeated every 6 weeks, for a maximum of 6 cycles with an ARPI (abiraterone or enzalutamide administered continuously starting on day 1. |
| Phase II: Arm 2 | EXPERIMENTAL | Participants will receive AAA617 on day 1 followed by AMO959 BID (days 2-15), repeated every 6 weeks, for a maximum of 6 cycles with an ARPI (abiraterone or enzalutamide) administered continuously starting on day 1. |
| Phase II: Arm 3 | EXPERIMENTAL | Participants will receive AAA617 every 6 weeks for a maximum of 6 cycles, with ARPI (abiraterone or enzalutamide) administered continuously starting on day 1. |
| Name | Type | Description |
|---|---|---|
| AMO959 | DRUG | DNA Damage Response inhibitor |
| AAA617 | RADIATION | PSMA-targeted radiopharmaceutical |
| Enzalutamide | DRUG | Androgen receptor pathway inhibitor |
| Abiraterone | DRUG | Androgen receptor pathway inhibitor |
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 histologically confirmed adenocarcinoma of the prostate. P...
AMO959 is an investigational small molecule being studied for PSMA-positive metastatic castration resistant prostate cancer (mCRPC) in patients who have had prior exposure to one androgen receptor pathway inhibitor (ARPI) and are candidates for taxane-based chemotherapy. It is currently in Phase 1 clinical development.
AMO959 is being studied in combination with Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and an ARPI in patients with PSMA-positive mCRPC. The treatment approach is directed at PSMA-positive tumors, though the specific molecular target of AMO959 itself is not disclosed.
AMO959 is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker NVS. The company is conducting clinical trials of AMO959 in multiple countries for the treatment of PSMA-positive metastatic castration resistant prostate cancer.
AMO959 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is a Phase Ib/II open-label study, currently recruiting participants with PSMA-positive mCRPC.
AMO959 is being evaluated in a Phase Ib/II open-label study with the National Clinical Trial identifier NCT07226986. The trial is recruiting 123 adult male participants across the United States, Australia, France, Germany, Italy, Japan, and Spain, and is studying AMO959 in combination with Lutetium (177Lu) Vipivotide Tetraxetan and an ARPI.
AMO959 is not the same as Lutetium (177Lu) Vipivotide Tetraxetan. AMO959 is a separate investigational small molecule being studied in combination with Lutetium (177Lu) Vipivotide Tetraxetan (also known as AAA617) and an androgen receptor pathway inhibitor in patients with PSMA-positive metastatic castration resistant prostate cancer.