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| ID | Type | Description | Link |
|---|---|---|---|
| 88998377LYM1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-509258-71-00 | Registry Identifier | EUCT number |
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The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Dose Escalation | Experimental | Participants will receive JNJ-88998377 at a selected starting dose. Subsequent dose levels and schedules will be selected based on the review of all available data to establish recommended Phase 2 dose (RP2D). |
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| Part B: Dose Expansion | Experimental | Participants will receive JNJ-88998377 at RP2D determined in Part A. Additional expansion cohort(s) may be added with a lower RP2D(s), or different dose schedule(s) based on all available data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-88998377 | Drug | JNJ-88998377 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. | Upto 3 years 4 months |
| Part A: Number of Participants with Dose Limiting Toxicity (DLTs) | Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity. | Cycle 1 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of JNJ-88998377 | Plasma concentration of oral dose of JNJ-88998377 will be assessed. | Up to first 12 weeks |
| Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | 100142 | China | |||
| Sun Yat Sen University Cancer Center |
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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Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported.
| Up to first 12 weeks |
| Maximum Plasma Concentration (Cmax) of JNJ-88998377 | Cmax of JNJ-88998377 will be reported. | Up to first 12 weeks |
| Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377 | Cmin of JNJ-88998377 will be reported. | Up to first 12 weeks |
| Percentage of Participants With Overall Response (OR) | OR is defined as the percentage of participants who have a best response of partial response (PR) or better per investigator assessment according to disease-specific response criteria. | Up to 3 years 4 months |
| Time to Response (TTR) | TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better per investigator assessment according to disease-specific response criteria. | From first dose of study treatment until first response of PR or better (up to 3 years and 4 months) |
| Duration of Response (DOR) | DOR is defined for participants who achieved a response of PR or better as 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. | From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months) |
| Guangzhou |
| 510062 |
| China |
| The First Affiliated Hospital Zhejiang University College of Medicine | Hangzhou | 310002 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | 300181 | China |
| A O U Sant Orsola Malpighi | Bologna | 40138 | Italy |
| National Cancer Center Hospital | Chūōku | 104 0045 | Japan |
| National Cancer Center Hospital East | Kashiwa | 277-8577 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135 8550 | Japan |
| Pratia Onkologia Katowice | Katowice | 40 519 | Poland |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku | Kielce | 25-734 | Poland |
| Aidport Sp z o o | Skorzewo | 60-185 | Poland |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| National Taiwan University Hospital | Taipei | 10043 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | 33382 | Taiwan |
| SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi | Ankara | 06200 | Turkey (Türkiye) |
| Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi | Ankara | 06620 | Turkey (Türkiye) |
| Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi | Istanbul | 34010 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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