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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07082920 | A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer | PHASE1 | RECRUITING | 140 | — | — | Jul 7, 2025 | Mar 1, 2027 | Jun 5, 2026 | 6 | United States, United Kingdom |
| NCT06095089 | A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer | PHASE1 | RECRUITING | 355 | — | — | Nov 1, 2023 | Jun 28, 2028 | Jun 5, 2026 | 15 | United States, France +1 |
| NCT04898634 | A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 216 | — | — | Jul 13, 2021 | Feb 10, 2027 | Jun 5, 2026 | 17 | United States, China +4 |
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.
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 |
|---|---|---|
| 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 2: Dose Expansion | EXPERIMENTAL | Participants will receive JNJ-78278343 in combination with JNJ-95298177 at the RP2CD as determined in Part 1 of the study to confirm the safety and anti-tumor activity. |
| 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 | 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 |
|---|---|---|
| JNJ-78278343 | DRUG | JNJ-78278343 will be administered intravenously. |
| JNJ-95298177 | DRUG | JNJ-95298177 will be administered intravenously. |
| JNJ-87189401 | DRUG | JNJ-87189401 will be administered. |
| 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. |
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example \[e.g.\], immunohis...