Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pasritamig · 4 trials · 5 indications
rPFS by CT/MRI or bone scan is assessed by BICR and is defined as the time from the date of randomization to the first date of radiographic disease progression, or death due to any cause, whichever occurs first.
OS is defined as the time from randomization to date of death due to any cause.
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. 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. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines and ocular events will be graded using the alternative scale provided in the protocol.
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.
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+Docetaxel | EXPERIMENTAL | Participants will receive pasritamig along with docetaxel until the end of treatment (EOT) visit or until radiographic disease progression is confirmed by blinded independent central review (BICR), or any other protocol defined criteria are met. |
| Docetaxel | ACTIVE_COMPARATOR | Participants will receive docetaxel along with prednisone/prednisolone as background medication. |
| Part 1: Pasritamig+Best Supportive Care (BSC) | EXPERIMENTAL | Participants in Part 1 will receive 2 step-up doses of pasritamig intravenously (IV) followed by the target dose. 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. |
| Part 1: Placebo+BSC | PLACEBO_COMPARATOR | Participants in Part 1 will receive 2 step-up doses of placebo IV followed by the target dose. 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. |
| Part 2: Pasritamig+BSC | EXPERIMENTAL | Participants in Part 2 will receive 2 step-up doses of pasritamig IV followed by the target dose. 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. |
| Part 2: Pasritamig+JNJ-87189401+BSC | EXPERIMENTAL | Participants in Part 2 will receive 2 step-up doses of pasritamig IV followed by the target dose. JNJ-87189401 will be administered with the first target dose of pasritamig. 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. |
| Part 2: Placebo +BSC | PLACEBO_COMPARATOR | Participants in Part 2 will receive 2 step-up doses of placebo IV followed by the target dose. 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. |
| Part 1: Dose Finding | EXPERIMENTAL | Participants will receive pasritamig in combination with JNJ-86974680 to determine the recommended phase 2 combination dose (RP2CD) regimen. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will receive pasritamig in combination with JNJ-86974680 at the RP2CD as determined in Part 1 of the study to confirm the safety and anti-tumor activity. |
| 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 | DRUG | Pasritamig will be administered. |
| Docetaxel | DRUG | Docetaxel will be administered. |
| Prednisone/Prednisolone | DRUG | Prednisone/Prednisolone will be administered. |
| 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. |
| JNJ-87189401 | BIOLOGICAL | JNJ-87189401 will be administered. |
| JNJ-86974680 | DRUG | JNJ-86974680 will be administered orally. |
| Cetrelimab | DRUG | Cetrelimab will be administered by intravenous infusion. |
| Cabazitaxel | DRUG | Cabazitaxel 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: * Have histologically confirmed adenocarcinoma of the prostate * Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m\^Tc bone scan as determined by the investigator * Participants must receive ongoing a...
Pasritamig is an investigational small molecule being developed for prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer. It is being studied in combination with other agents and as part of treatment regimens for these advanced prostate cancer indications.
Pasritamig is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in clinical development for prostate cancer indications, with multiple trials ongoing.
Pasritamig is in Phase 1 and Phase 3 clinical trials. It is an investigational drug, not yet approved by regulatory authorities. The Phase 3 trials are studying it in metastatic castration-resistant prostate cancer, while Phase 1 trials are exploring combinations for earlier-stage prostate cancer.
Pasritamig is being studied in four recruiting trials: NCT05818683, a Phase 1 combination study for metastatic prostate cancer; NCT07164443, a Phase 3 trial with or without JNJ-87189401 versus placebo for late-line mCRPC; NCT07225946, a Phase 3 trial with docetaxel for mCRPC; and NCT07319871, a Phase 1 combination study for prostate cancer.
Yes, Pasritamig is also known as JNJ-78278343. Clinical trial titles refer to the drug by this alternative name, such as in the study of Pasritamig (JNJ-78278343) in combination with other agents for metastatic prostate cancer.