Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BY1298, BY101298
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 developed by Novartis AG for PSMA-positive metastatic castration resistant prostate cancer (mCRPC). It is being studied in adults who have had prior exposure to one ARPI and who are candidates for taxane-based chemotherapy. It is a Phase 1 asset and is not approved for any use.
AMO959 is being developed for PSMA-positive metastatic castration resistant prostate cancer (mCRPC) in patients with prior exposure to one prior ARPI who are candidates for taxane-based chemotherapy. The program is biomarker selected, meaning patients are chosen based on PSMA expression. It remains investigational and is not approved for treating prostate cancer.
AMO959 targets PSMA, or prostate-specific membrane antigen, a protein expressed on prostate cancer cells. Because the trial enrolls only PSMA-positive patients, PSMA serves as both the molecular target and the biomarker used to select participants. AMO959 is a small molecule directed at this target.
AMO959 is developed by Novartis AG, which trades under the ticker NVS. Novartis is running the clinical program for the asset in PSMA-positive metastatic castration resistant prostate cancer. No other developer or partner is listed for AMO959.
AMO959 is in Phase 1 development. The only registered study is a Phase Ib/II open-label trial, and it is currently recruiting. Because it is still in clinical development, AMO959 is investigational and has not been approved by the FDA or any other regulator for commercial use.
AMO959 is being studied in one recruiting trial, NCT07226986, titled a Phase Ib/II open-label study of AMO959 with lutetium (177Lu) vipivotide tetraxetan (AAA617) in combination with an ARPI in adults with PSMA-positive mCRPC. The trial plans to enroll 123 male participants aged 18 and older across the United States, Australia, France, Germany, Italy, Japan, and Spain.