Clinical Trials in South Korea / NCT07223125
Recruiting
Phase 1
A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors
NCT07223125 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Advanced-stage Solid Tumors
Investigational drug(s) / intervention(s)
JNJ-89862175
JNJ-89862175: JNJ-89862175 will be administered.
Study summary
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.
Eligibility
Inclusion Criteria:
* Participants must have histologically or cytologically confirmed, metastatic or unresectable solid tumor of lung adenocarcinoma, renal cell carcinoma (RCC): clear cell or papillary carcinoma, endometrioid ovarian cancer and endometrioid uterine carcinoma
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening
* Participants on study drug and for 4 months after the last dose of study drug must not breastfeed or be pregnant, not donate gametes (that is, eggs or sperms) or freeze for future use for the purposes of assisted reproduction and wear an external condom
Exclusion Criteria:
* Active central nervous system (CNS) involvement unless clinically stable
* History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
* History of solid organ or hematologic stem cell transplantation
* Known allergies, hypersensitivity, or intolerance to excipients of JNJ-89862175
* Has prior or concurrent second malignancy (other than the disease under study) in which the natural history or treatment is likely to interfere with safety endpoints or efficacy of the study drug
Primary outcome measure(s)
- Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs) — Up to 21 days
The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation. - Part 1: Number of Participants with Adverse Events (AEs) by Severity — Up to 2 years and 10 months
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. - Part 2: Number of Participants with Adverse Events (AEs) by Severity at RP2D — Up to 2 years and 10 months
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.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| AdventHealth Orlando | Orlando | Florida | Recruiting |
| NEXT Oncology | Irving | Texas | Recruiting |
| Centre Leon Berard | Lyon | France | Recruiting |
| Gustave Roussy | Villejuif | France | Recruiting |
| Severance Hospital Yonsei University Health System | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
More Janssen Research & Development, LLC trials in South Korea
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07223125 on ClinicalTrials.gov ↗ ← All trials in South Korea