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NCT06178614PHASE1Recruiting

A Study of JNJ-87890387 for Advanced Solid Tumors

Janssen Research & Development, LLC

Start Date

12/14/2023

Completion Date

2/7/2029

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

JNJ-87890387

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Conditions

NeoplasmsAdvanced Solid Tumors

Locations

Start Midwest

Grand Rapids, Michigan 49546

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

Centre Leon Berard

Lyon, 69008

France

Institut Gustave Roussy

Villejuif, 94805

France

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain