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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06311578 | A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors | PHASE1 | RECRUITING | 126 | — | — | Apr 10, 2024 | Aug 26, 2032 | Jun 5, 2026 | 10 | United States, Canada +2 |
The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. 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, 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 | EXPERIMENTAL | Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested. |
| Part 2: Dose Expansion | EXPERIMENTAL | Part 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A\&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC. |
| Name | Type | Description |
|---|---|---|
| JNJ-87704916 | DRUG | JNJ-87704916 will be administered as an intratumoral injection. |
| Cetrelimab | DRUG | Cetrelimab will be administered. |
| Standard of Care PD(L)-1 | DRUG | Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment. |
Inclusion Criteria: * For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC * Have at least 1 injectable tumor * Easter...