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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06255665 | A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors | PHASE1 | COMPLETED | 35 | — | — | Feb 9, 2024 | Jun 23, 2025 | Jul 20, 2025 | 3 | Spain |
The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. 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 (ICANS), 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 |
|---|---|---|
| Part 1 (Dose Escalation): JNJ-79032421 | EXPERIMENTAL | In Part 1 (Dose escalation), participants will receive JNJ-79032421. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. |
| Part 2 (Dose Expansion): JNJ-79032421 | EXPERIMENTAL | In Part 2 (Dose expansion), participants will receive JNJ-79032421 at the RP2D regimen(s) determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-79032421 | DRUG | JNJ-79032421 will be administered. |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of one of the following unresectable/locally advanced or metastatic solid tumors: a) Ovarian cancer includes high grade serous epithelial ovary, fallopian tube, or primary peritoneal cancer. Participants must have progressed ...