Testing JNJ-87890387 for advanced solid tumors
A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors
This study is testing a new drug called JNJ-87890387 to see how safe it is and what the right dose is for people with advanced solid tumors like kidney cancer, ovarian cancer, and lung cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | immunotherapy, prednisone |
| Locations | 6 sites (Grand Rapids, Michigan and 5 other locations) |
| Trial ID | NCT06178614 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the recommended phase 2 doses (RP2Ds) of the drug JNJ-87890387 and assess its safety in patients with advanced solid tumors. Participants will have confirmed metastatic or unresectable solid tumors, including specific types such as renal cell cancer, endometrioid ovarian cancer, and lung adenocarcinoma. The study will involve measuring the disease's response to the treatment and collecting tumor tissue samples for analysis. The trial is structured in two parts, focusing on both measurable and evaluable disease.
Who should consider this trial
Good fit: Ideal candidates include individuals with specific types of advanced solid tumors who have measurable or evaluable disease.
Not a fit: Patients with early-stage tumors or those who do not meet the specific tumor type criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.
How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced solid tumors, but this specific drug is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have histologically or cytologically confirmed, metastatic, or unresectable solid tumor of one of the following types: a) Renal cell cancer (RCC)-clear cell or papillary carcinoma; b) Endometrioid ovarian cancer c) Endometrioid uterine carcinoma; d) Colorectal adenocarcinoma (CRC); e) Lung adenocarcinoma * Have measurable or evaluable disease: Part 1- Either measurable or evaluable disease; Part 2- At least 1 measurable lesion per RECIST v1.1. Participants with ovarian cancer without a measurable lesion must have disease evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or have cancer antigen (CA) 125 greater than (\>) 2\*upper limit of normal (ULN) during screening * All participants in Part 1 and Part 2 must consent to provide an archived tumor tissue sample at screening * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening * Be willing and able to adhere to the lifestyle restrictions specified in this protocol. Exclusion Criteria: * Active Central Nervous System (CNS) involvement with the exception of locally treated brain metastases that are clinically stable and asymptomatic for \> 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \[\<=\]10 milligrams \[mg\] prednisone or equivalent) for at least 2 weeks prior to start of study treatment * Toxicity from prior anticancer therapy that has not resolved to Grade \<=1 (except alopecia, vitiligo, Grade \<=2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement) * History of Grade greater than or equal to (\>=) 2 immune-related AE(s) with prior immunotherapy that led to discontinuation of previous immunotherapy with the exception of Grade 2 and Grade 3 immune-related AEs that responded to treatment and that did not recur following rechallenge. Endocrinopathies that are stable on hormone replacement therapy or that have resolved are allowed. * History of solid organ or hematologic stem cell transplantation * Any episode of partial or complete bowel obstruction requiring hospitalization within 30 days prior to first dose of study treatment
Where this trial is running
Grand Rapids, Michigan and 5 other locations
- Start Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- Centre Leon Berard — Lyon, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
- Hosp Univ Vall D Hebron — Barcelona, Spain (Recruiting)
- Hosp. Univ. 12 de Octubre — Madrid, Spain (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.