Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pasritamig, KLK2-CD3
JNJ-78278343 · 8 trials · 6 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.
Proportion of participants who complete planned neoadjuvant pasritamig and undergo radical prostatectomy within the protocol-defined surgical window without treatment-related delay.
Measured as CD3-positive T cells per mm² of evaluable tumor area
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 (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
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.
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.
| 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. |
| Neoadjuvant Pasritamig | EXPERIMENTAL | Participants receive pasritamig IV on days 1, 8, 15, and 57. Participants then undergo standard of care radical prostatectomy. Participants also undergo blood and tissue sample collection on study. |
| 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. |
| Part 1: Dose Confirmation | EXPERIMENTAL | Participants will receive JNJ-78278343 in combination with JNJ-95298177 in a dose de-escalation schedule in accordance with the Bayesian Optimal Interval Design (BOIN) design to determine the recommended phase 2 combination dose (RP2CD) regimen. |
| Part 1 (Dose Escalation) | EXPERIMENTAL | Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). |
| Part 2 (Dose Expansion) | EXPERIMENTAL | Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet. |
| Part 3 | EXPERIMENTAL | Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision. |
| Part 4 | EXPERIMENTAL | Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations. |
| 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). |
| JNJ-78278343 | EXPERIMENTAL | Participants will receive JNJ-78278343. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by the study evaluation team (SET) in Part 1 (dose escalation). In Part 2 (dose expansion), participants will receive JNJ-78278343 at recommended phase 2 dose (RP2D) as determined in Part 1. Participants who are still on study treatment (i.e., who are in Treatment Phase) at the time of the long term extension (LTE) will continue to receive study treatment until they reach a reason for discontinuation of treatment or until further notification by the sponsor of a different means for continued supply of study treatment, whichever occurs first. |
| 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. |
| JNJ-78278343 | DRUG | JNJ-78278343 will be administered intravenously. |
| JNJ-95298177 | DRUG | JNJ-95298177 will be administered intravenously. |
| Apalutamide | DRUG | Apalutamide will be administered. |
| Lutetium Lu-177 Vipivotide Tetraxetan | DRUG | Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. |
| JNJ-101556143 | DRUG | JNJ-101556143 will be administered. |
| Cetrelimab | DRUG | Cetrelimab will be administered by intravenous infusion. |
| Cabazitaxel | DRUG | Cabazitaxel will be administered by intravenous infusion. |
| 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. |
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...
JNJ-78278343 is an investigational small molecule being developed for the treatment of prostate cancer, specifically prostatic neoplasms. It is currently in Phase 1 clinical trials, which are studying the drug both as a monotherapy and in combination with other agents for advanced prostate cancer.
JNJ-78278343 targets KLK2, also known as human kallikrein 2. It is described as a T-cell-redirecting agent that targets this protein, which is associated with prostate cancer cells. This mechanism is being evaluated in clinical trials for the treatment of advanced prostate cancer.
JNJ-78278343 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for prostate cancer.
JNJ-78278343 is in Phase 1 clinical trials. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical development to evaluate its safety and efficacy in patients with prostate cancer.
JNJ-78278343 is being studied in three Phase 1 clinical trials. NCT04898634 evaluates it as a monotherapy for advanced prostate cancer. NCT06095089 studies it in combination with JNJ-87189401, and NCT07082920 studies it in combination with JNJ-95298177. All trials enroll male patients aged 18 and older.
No, JNJ-78278343 and JNJ-87189401 are different investigational drugs. They are being studied together in a Phase 1 clinical trial (NCT06095089) for advanced prostate cancer, but they are distinct agents with separate mechanisms and are not alternative names for the same compound.