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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07525141 | A Study of JNJ-1761981 in Participants With Solid Tumors | PHASE1 | RECRUITING | 66 | — | — | May 26, 2026 | Jan 31, 2029 | Jun 5, 2026 | 2 | United States |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Participants with AEs related to delivery device and/or procedure will be reported.
Number of participants who received planned total dose per level will be reported.
Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve complete response (CR) or partial response (PR).
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive JNJ-1761981 intratumorally to determine a safe and tolerable total JNJ-1761981 dose. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants in Cohort A will receive JNJ-1761981 at specified volumetric doses. Participants who receive more than 1 dose of JNJ-1761981 may receive optional systemic therapy with cetrelimab at the discretion of the treating physician. |
| Name | Type | Description |
|---|---|---|
| JNJ-1761981 | DRUG | JNJ-1761981 will be administered intratumorally. |
| Cetrelimab | DRUG | Cetrelimab will be administered intravenously. |
Inclusion criteria: * Part 1: Individuals with a diagnosis of locally advanced or metastatic disease (solid tumors except tumors of the central nervous system \[CNS\]) who have previously received available standard therapy and progressed, or cannot tolerate standard therapy, or for whom there is n...