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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02829099 | A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors | PHASE1 | COMPLETED | 95 | — | — | Sep 21, 2016 | Jul 29, 2021 | Oct 6, 2022 | 4 | Israel, Spain |
Dose-limiting toxicities will be reviewed as a subset of adverse events that occur within the first 28 days of dosing and meet protocol-specified criteria.
| Arm | Type | Description |
|---|---|---|
| JNJ-64457107 | EXPERIMENTAL | In Part 1, the first cohort will receive JNJ-64457107 at a starting dose of 75 microgram per kilogram (mcg/kg). The proposed treatment schedule is intravenous (IV) dosing every 14 days. JNJ-64457107 doses will be escalated following a modified Continual Reassessment Method (mCRM); the JNJ-64457107 dose will be increased by not more than half-logarithmical (3.2-fold) dose increments. Dose escalation will continue until the maximum tolerated dose (MTD) and/or RP2D of JNJ-64457107 are defined or the maximum-administered dose (MAD) has been reached. In Part 2, subjects will receive JNJ-64457107 at the RP2D and regimen determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-64457107 | DRUG | JNJ-64457107 administered by IV infusion on Day 1 and 14 of a 28-day cycle. |
Inclusion Criteria: * Part 1: advanced stage solid tumors; Part 2: non-small cell lung cancer (NSCLC), pancreatic cancer and cutaneous melanoma * Eastern cooperative oncology group (ECOG) performance score of 0 or 1 * Adequate organ function as defined in the protocol * A woman of childbearing pote...