A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors
Purpose
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.
Condition
- Advanced-stage Solid Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Participants may be randomized in Part 2
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental JNJ-89862175 |
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. |
|
Recruiting Locations
AdventHealth Orlando
Orlando 4167147, Florida 4155751 32803
Orlando 4167147, Florida 4155751 32803
NEXT Oncology
Irving 4700168, Texas 4736286 75039
Irving 4700168, Texas 4736286 75039
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC