A Study of JNJ-87890387 for Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Neoplasms, Advanced Solid Tumors
In brief
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).
Key facts
- Study ID
- NCT06178614
- Run by
- Janssen Research & Development, LLC
- People needed
- 200
- Starts
- 2023-12-14
- Expected to finish
- 2029-02-07
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Start Midwest — Grand Rapids, Michigan, United States (enrolling)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
- Centre Leon Berard — Lyon, France (enrolling)
- Institut Gustave Roussy — Villejuif, France (enrolling)
- Hosp Univ Vall D Hebron — Barcelona, Spain (enrolling)
- Hosp. Univ. 12 de Octubre — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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