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| ID | Type | Description | Link |
|---|---|---|---|
| 95437446LUC1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2025-521535-36-00 | Registry Identifier | EUCT number |
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The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-95437446 | Experimental | Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-95437446 | Drug | JNJ-95437446 will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) by Severity | 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. | Up to 2 years and 4 months |
| Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) | The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation. | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate (ORR) is defined as the percentage of participants who have best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST). | Up to 2 years and 4 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists | Recruiting | Sarasota | Florida | 34232 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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DOR is defined for the responders from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST version (v.) 1.1, or death due to any cause, whichever occurs first. |
| Up to 2 years and 4 months |
| Progression Free Survival (PFS) | PFS is defined as the time from the first dose of JNJ-95437446 to either progressive disease (PD) or death due to any cause, whichever comes first. | Up to 2 years and 4 months |
| Maximum Plasma Concentration (Cmax) for JNJ-95437446 | Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite. | Up to 2 years and 4 months |
| Time to Reach Cmax (Tmax) for JNJ-95437446 | Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported. | Up to 2 years and 4 months |
| Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite. | AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported. | Up to 2 years and 4 months |
| Number of Participants With Anti JNJ-95437446 Antibodies | Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a validated assay method. | Up to 2 years and 4 months |
| Columbia University Medical Center Herbert Irving Pavilion |
| Recruiting |
| New York |
| New York |
| 10032 |
| United States |
| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
| NEXT Oncology | Recruiting | Fairfax | Virginia | 22031 | United States |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 8035 | 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |