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JNJ-95437446 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. 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) 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.
The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.
| Arm | Type | Description |
|---|---|---|
| JNJ-95437446 | EXPERIMENTAL | Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. In selected participants in Part 1, amivantamab may also be co-dosed with JNJ-95437446. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-95437446 | DRUG | JNJ-95437446 will be administered. |
| Amivantamab | DRUG | Amivantamab will be administered. |
Inclusion Criteria: * Participants must have been previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma * Participants with non-small cell lung cancer (NSCLC) adenoc...
JNJ-95437446 is an investigational small molecule being developed for the treatment of colorectal neoplasms. It is currently being studied in a Phase 1 clinical trial in participants with advanced-stage solid tumors, which includes colorectal cancer. The drug is not yet approved and remains in clinical development.
JNJ-95437446 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced-stage solid tumors.
JNJ-95437446 is in Phase 1 clinical development. It is an investigational drug being studied in a recruiting trial for participants with advanced-stage solid tumors. The drug has not been approved by regulatory authorities and is still undergoing early-stage clinical testing.
JNJ-95437446 is being evaluated in a single Phase 1 clinical trial registered as NCT07107230. This study, titled "A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors," is currently recruiting participants in the United States, South Korea, and Spain. The trial is an uncontrolled, open-label study.
The Phase 1 trial of JNJ-95437446, NCT07107230, aims to enroll approximately 400 participants aged 18 years and older with advanced-stage solid tumors. The study is recruiting in the United States, South Korea, and Spain. It is an uncontrolled trial that is not randomized or double-blinded.