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| ID | Type | Description | Link |
|---|---|---|---|
| 89862175LUC1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2025-521407-52-00 | Registry Identifier | EUCT number |
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The purpose of this study is to determine safe and effective dose (recommended phase 2 doses [RP2Ds]) of JNJ-89862175 in Part 1 (dose escalation), and to further evaluate how safe JNJ-89862175 is at the RP2Ds in Part 2 (dose expansion) in participants with advanced stage solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-89862175 | Experimental | Participants will receive JNJ-89862175 in Part 1 to determine the recommended phase 2 doses (RP2Ds). Dose-escalation and de-escalation will be based on study evaluation team (SET) decision. In Part 2, participants will receive JNJ-89862175 at the RP2Ds determined in Part 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-89862175 | Drug | JNJ-89862175 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs) | 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 |
| Part 1: 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 10 months |
| Part 2: Number of Participants with Adverse Events (AEs) by Severity at RP2D | 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 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 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants who have best overall response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v.) 1.1. | Up to 2 years and 10 months |
| Progression Free Survival (PFS) |
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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 |
|---|---|---|---|---|---|---|
| AdventHealth Orlando | Recruiting | Orlando | Florida | 32803 | United States | |
| NEXT Oncology |
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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Participants may be randomized in Part 2
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PFS is defined as the time from the first dose of JNJ-89862175 to either disease progression according to RECIST v. 1.1, or death due to any cause, whichever comes first. |
| Up to 2 years and 10 months |
| Duration of Response (DOR) | DOR is defined as the time from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST v. 1.1, or death due to any cause, whichever occurs first. | Up to 2 years and 10 months |
| Maximum Plasma Concentration (Cmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | Serum samples will be analyzed to determine Cmax of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite. | Up to 2 years and 10 months |
| Observed Plasma Concentration Immediately Before Next Dose Administration (Ctrough) of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | Ctrough of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported. | Up to 2 years and 10 months |
| Time to Reach Cmax (Tmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported. | Up to 2 years and 10 months |
| Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported. | Up to 2 years and 10 months |
| Accumulation Ratio of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | Accumulation ratio of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported. | Up to 2 years and 10 months |
| Number of Participants With Anti JNJ-89862175 Antibodies | Serum samples will be analyzed for the detection of anti-JNJ-89862175 antibodies using a validated assay method. | Up to 2 years and 10 months |
| Recruiting |
| Irving |
| Texas |
| 75039 |
| United States |
| Centre Leon Berard | Recruiting | Lyon | 69373 | France |
| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |