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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07164443 | A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) | PHASE3 | RECRUITING | 663 | — | — | Sep 2, 2025 | Dec 29, 2027 | Jun 5, 2026 | 168 | United States, Australia +15 |
| NCT05818683 | A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer | PHASE1 | RECRUITING | 300 | — | — | Apr 26, 2023 | May 23, 2028 | Jun 5, 2026 | 15 | United States, Australia +1 |
OS is defined as the time from randomization to date of death due to any cause.
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
| Arm | Type | Description |
|---|---|---|
| Pasritamig Plus Best Supportive Care (BSC) | EXPERIMENTAL | Participants will receive the step-up doses of pasritamig intravenously (IV) on Cycle 1 Day 1 (C1D1) and C1D8, and target dose of pasritamig IV on C1D15. From C2D1 onwards participants will receive pasritamig target dose IV every 6 weeks. All Cycles are 6 weeks, except for Cycle 1 which is 8 weeks. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician. |
| Placebo Plus BSC | PLACEBO_COMPARATOR | Participants will receive the step-up doses of placebo IV on C1D1 and C1D8, and target dose of placebo on C1D15. From C2D1 onwards, participants will receive placebo target dose IV every 6 weeks. All Cycles are 6 weeks, except for Cycle 1 which is 8 weeks. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC at the discretion of the physician. |
| JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) | EXPERIMENTAL | Participants will receive pasritamig (JNJ-78278343) and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone, Lutetium Lu-177 vipivotide tetraxetan and JNJ-101556143) during Part 1 (dose escalation). The dose of pasritamig (JNJ-78278343) will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive pasritamig (JNJ-78278343) and combination agent treatment at the putative RP2R in Part 2 (dose expansion). |
| Name | Type | Description |
|---|---|---|
| Pasritamig | BIOLOGICAL | Pasritamig will be administrated through IV infusion. |
| Placebo | OTHER | Placebo will be administrated through IV infusion. |
| Best Supportive Care (BSC) | DRUG | BSC will be administered at the discretion of the treating physician. |
| Cetrelimab | DRUG | Cetrelimab will be administered by intravenous infusion. |
| Cabazitaxel | DRUG | Cabazitaxel will be administered by intravenous infusion. |
| Docetaxel | DRUG | Docetaxel will be administered by intravenous infusion. |
| Apalutamide | DRUG | Apalutamide will be administered orally. |
| Enzalutamide | DRUG | Enzalutamide will be administered orally. |
| Darolutamide | DRUG | Darolutamide will be administered orally. |
| Abiraterone acetate plus prednisone (AAP) | DRUG | Abiraterone acetate plus prednisone (AAP) will be administered orally. |
| Lutetium Lu-177 vipivotide tetraxetan | DRUG | Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously. |
| JNJ-101556143 | DRUG | JNJ-101556143 will be administered orally. |
Inclusion Criteria * Histologically confirmed adenocarcinoma of the prostate * Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imagin...