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A Study of JNJ-87890387 for Advanced Solid Tumors

RECRUITINGPhase 1Sponsored by Janssen Research & Development, LLC
Actively Recruiting
PhasePhase 1
SponsorJanssen Research & Development, LLC
Started2023-12-14
Est. completion2027-03-16
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Advanced Solid TumorsCancerNeoplasms

Locations2 sites

Michigan

1 site
Start Midwest
Grand Rapids, Michigan, 49546

Tennessee

1 site
Sarah Cannon Research Institute
Nashville, Tennessee, 37203

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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