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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516526-66-00 | Registry Identifier | EUCT number |
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The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-89402638 | Drug | JNJ-89402638 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity | 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. | From Baseline up to approximately 24 months |
| Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) | The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities. | From Baseline up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Serum Concentration for JNJ-89402638 | Serum Concentration for JNJ-89402638 will be reported. | Up to approximately 24 months |
| Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638 |
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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 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting
Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Anschultz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| 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. |
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| Bevacizumab | Drug | Bevacizumab or biosimilar will be administered. |
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| FOLFOX | Drug | Chemotherapy agent FOLFOX will be administered. |
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| FOLFIRI | Drug | Chemotherapy agent FOLFIRI will be administered. |
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Cmax of JNJ-89402638 will be reported.
| Up to approximately 24 months |
| Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638 | Cmin of JNJ-89402638 will be reported. | Up to approximately 24 months |
| Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638 | Tmax of JNJ-89402638 will be reported. | Up to approximately 24 months |
| Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638 | AUC of JNJ-89402638 will be reported. | Up to approximately 24 months |
| Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies | Participants with anti-JNJ-89402638 antibodies will be reported. | Up to approximately 24 months |
| Part 1 and Part 2: Overall Response (OR) | Overall response is best response of complete response (CR) or partial response (PR), assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1. | Up to approximately 24 months |
| Part 1 and Part 2: Complete Response (CR) | Complete response is defined as a best response of CR assessed according to RECIST version 1.1. | Up to approximately 24 months |
| Part 1 and Part 2: Time to Response (TTR) | TTR is defined for participants who achieved an OR from the time of the first dose of study treatment to the first response of PR or better as assessed according to RECIST version 1.1. | Up to approximately 24 months |
| Part 1 and Part 2: Duration of Response (DOR) | DOR is defined for participants who achieved an OR in the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death due to any cause, whichever occurs first, as assessed according to RECIST version 1.1 | Up to approximately 24 months |
| Florida Cancer Specialists |
| Recruiting |
| Sarasota |
| Florida |
| 34232 |
| United States |
| Community Health Network | Recruiting | Indianapolis | Indiana | 46256 | United States |
| Start Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| Swedish Cancer Institute | Recruiting | Seattle | Washington | 98104 | United States |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hosp Univ Fund Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hosp Univ Hm Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C410216 | Folfox protocol |
| C480833 | IFL protocol |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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