NCT06178614 A Study of JNJ-87890387 for Advanced Solid Tumors
| NCT ID | NCT06178614 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2027-03-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2023-12-14 with a primary completion date of 2027-03-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).
Eligibility 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
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT06178614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06178614 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06178614 currently recruiting?
Yes, NCT06178614 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT06178614 trial being conducted?
This trial is being conducted at Grand Rapids, United States, Nashville, United States, Lyon, France, Villejuif, France and 2 additional locations.
Who is sponsoring the NCT06178614 clinical trial?
NCT06178614 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 200 participants.