NCT07223125 · Janssen Research & Development, LLC
A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors
What this study is about
The purpose of this study is to determine safe and effective dose (recommended phase 2 doses \[RP2Ds\]) of JNJ-89862175 in Part 1 (gradually increasing doses), and to further evaluate how safe JNJ-89862175 is at the RP2Ds in Part 2 (dose expansion) in participants with advanced stage solid tumors.
View original scientific description
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.
Interventions
DRUG
JNJ-89862175
JNJ-89862175 will be administered.
Primary outcome measures
Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Orlando, Florida
- Irving, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2026 · Source of record for eligibility and locations