Approval Probability
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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 by Johnson & Johnson for the treatment of advanced stage solid tumors. It is currently in Phase 1 clinical development and is designed for use in biomarker-selected patients. It is not yet approved for any indication.
JNJ-95437446 is being studied for the treatment of advanced stage solid tumors. The Phase 1 trial enrolls adults with advanced-stage solid tumors and selects participants based on a biomarker. Because the drug remains investigational, it is not approved for any use outside of clinical research.
JNJ-95437446 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is running the clinical program for the asset in advanced stage solid tumors.
JNJ-95437446 is in Phase 1 clinical development. One Phase 1 trial is currently recruiting participants; no later-phase trials have been completed. As an investigational agent, JNJ-95437446 has not received FDA approval and is available only through clinical study participation.
JNJ-95437446 is being evaluated in the Phase 1 trial NCT07107230, titled A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors. The trial is recruiting up to 400 participants aged 18 years and older across the United States, South Korea, and Spain. It is an uncontrolled, non-randomized study.