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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06663319 | A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers | PHASE1 | RECRUITING | 220 | — | — | Oct 15, 2024 | Jul 19, 2028 | May 8, 2026 | 11 | United States, South Korea +1 |
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) 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) 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 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...