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JNJ-64457107 · 1 trial · 1 indication
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...
JNJ-64457107 is an investigational small molecule being studied for the treatment of advanced solid neoplasms. It is in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated for its safety, pharmacokinetics, and pharmacodynamics in patients with advanced stage tumors.
JNJ-64457107 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for advanced solid neoplasms.
JNJ-64457107 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study of the drug has been completed, evaluating its safety, pharmacokinetics, and pharmacodynamics in participants with advanced stage tumors.
JNJ-64457107 has one completed clinical trial, identified as NCT02829099. This Phase 1 study, titled "A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors," enrolled 95 participants with advanced solid neoplasms in Israel and Spain.
JNJ-64457107 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced solid neoplasms. The drug is being studied for safety, pharmacokinetics, and pharmacodynamics, but has not yet received regulatory approval.