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JNJ-89402638 · 1 trial · 2 indications
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus.
The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.
| Arm | Type | Description |
|---|---|---|
| Part 1 (Dose Expansion) | EXPERIMENTAL | Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) and optimal route(s) of administration for JNJ-89402638 monotherapy have been identified. |
| Part 2 (Dose Expansion): Arm A | EXPERIMENTAL | Participants with mCRC will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1 as a monotherapy. |
| Part 2 (Dose Expansion): Arm B | EXPERIMENTAL | Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar. |
| Part 2 (Dose Expansion): Arm C | EXPERIMENTAL | Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX. |
| Part 2 (Dose Expansion): Arm D | EXPERIMENTAL | Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI. |
| Part 2 (Dose Expansion): Arm E | EXPERIMENTAL | Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-89402638 | DRUG | JNJ-89402638 will be administered. |
| Bevacizumab | DRUG | Bevacizumab or biosimilar will be administered. |
| FOLFOX | DRUG | Chemotherapy agent FOLFOX will be administered. |
| FOLFIRI | DRUG | Chemotherapy agent FOLFIRI will be administered. |
Inclusion Criteria: * For Part 1 (dose escalation), Part 2 (Arm A \[JNJ-89402638 monotherapy\]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2...
JNJ-89402638 is an investigational small molecule being developed for the treatment of colorectal neoplasms, specifically metastatic colorectal cancer. It is also being studied in gastric cancers as part of the same clinical trial. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
JNJ-89402638 is being developed by Johnson & Johnson, a multinational pharmaceutical 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 safety and efficacy of this investigational drug in patients with advanced gastrointestinal cancers.
JNJ-89402638 is in Phase 1 clinical development. This is an early-stage trial designed to assess the drug's safety, tolerability, and preliminary efficacy in patients with metastatic colorectal and gastric cancers. The drug is investigational and has not received FDA approval for any indication.
JNJ-89402638 is being evaluated in a single Phase 1 clinical trial registered as NCT06663319, titled 'A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers.' The trial is currently recruiting participants in the United States, South Korea, and Spain, with a planned enrollment of 260 patients aged 18 years and older.
No alternative names for JNJ-89402638 have been disclosed in the available information. The drug is identified solely by its development code JNJ-89402638 in the clinical trial registry. It is a distinct investigational compound being developed by Johnson & Johnson for the treatment of colorectal and gastric cancers.