JNJ-89862175 treatment for advanced solid tumors
A Phase 1 Study of JNJ-89862175, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 Antibody Drug Conjugate, for Advanced Solid Tumors
PHASE1 · Janssen Research & Development, LLC · NCT07223125
This study will test JNJ-89862175 to find safe doses and see how it works in people with advanced solid tumors such as lung adenocarcinoma, certain renal cell cancers, and endometrioid ovarian and uterine cancers.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC (industry) |
| Locations | 6 sites (Orlando, Florida and 5 other locations) |
| Trial ID | NCT07223125 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label, multi-center study uses a two-part design: Part 1 is a dose-escalation to identify recommended Phase 2 dose(s) (RP2Ds) and Part 2 expands cohorts at the RP2Ds to further characterize safety and preliminary activity. Participants will receive JNJ-89862175 with scheduled safety monitoring, laboratory tests, and imaging to track adverse events and tumor response. Eligible patients have metastatic or unresectable lung adenocarcinoma, clear cell or papillary renal cell carcinoma, endometrioid ovarian cancer, or endometrioid uterine carcinoma and an ECOG performance status of 0–1. Key exclusions include active uncontrolled CNS disease, recent clinically significant cardiovascular events, prior solid organ or hematologic stem cell transplant, and known hypersensitivity to the drug's excipients.
Who should consider this trial
Good fit: Adults with histologically confirmed metastatic or unresectable lung adenocarcinoma, clear cell or papillary renal cell carcinoma, endometrioid ovarian cancer, or endometrioid uterine carcinoma who have ECOG 0–1 and meet the study's reproductive and safety requirements are the intended candidates.
Not a fit: Patients with active, uncontrolled CNS metastases, recent significant cardiovascular disease, prior organ or stem cell transplant, known hypersensitivity to the drug's excipients, or those with tumor types not listed are unlikely to qualify or benefit from this study.
Why it matters
Potential benefit: If successful, JNJ-89862175 could provide a new treatment option and potentially improve disease control for some patients with these advanced solid tumors.
How similar studies have performed: The two-part Phase 1 dose-escalation and expansion approach is standard for early oncology development; while some similar targeted agents have produced benefit in selected cancers, this specific compound is at an early stage with limited published human efficacy data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Orlando, Florida and 5 other locations
- AdventHealth Orlando — Orlando, Florida, United States (RECRUITING)
- NEXT Oncology — Irving, Texas, United States (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)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced-stage Solid Tumors