Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07213674 | A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer | PHASE3 | RECRUITING | 750 | — | — | Nov 28, 2025 | Aug 30, 2032 | Jun 4, 2026 | 133 | United States, Australia +16 |
| NCT06691984 | Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute) | PHASE3 | ACTIVE NOT_RECRUITING | 707 | — | — | Dec 9, 2024 | Jul 30, 2029 | May 15, 2026 | 164 | United States, Australia +20 |
| Arm | Type | Description |
|---|---|---|
| Xaluritamig Plus Abiraterone | EXPERIMENTAL | Participants will be randomized to receive xaluritamig in combination with abiraterone acetate. |
| Investigator's Choice | ACTIVE_COMPARATOR | Participants will receive investigator's choice of: * Abiraterone acetate orally, once daily or * Docetaxel IV Q3W or * Cabazitaxel IV Q3W. |
| Xaluritamig | EXPERIMENTAL | Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion. |
| Cabazitaxel/Abiraterone/Enzalutamide | ACTIVE_COMPARATOR | Participants with mCRPC will be randomized to receive cabazitaxel as an IV infusion, or a second androgen receptor-directed therapy of either abiraterone as oral tablets, or enzalutamide as oral tablets at the investigator's discretion. |
| Name | Type | Description |
|---|---|---|
| Xaluritamig | DRUG | Xaluritamig will be administered IV. |
| Abiraterone acetate | DRUG | Abiraterone acetate will be administered orally. |
| Docetaxel | DRUG | Docetaxel will be administered IV. |
| Cabazitaxel | DRUG | Cabazitaxel will be administered IV. |
| Abiraterone | DRUG | Oral tablets |
| Enzalutamide | DRUG | Oral tablets |
Inclusion Criteria: * Participant has provided informed consent before initiation of any study-specific activities/procedures. * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. * Participant must have histological, patholo...