A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors

NCT ID: NCT07223125

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2028-08-15

Brief Summary

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The purpose of this study is to determine safe and effective dose (recommended phase 2 doses \[RP2Ds\]) of JNJ-89862175 in Part 1 (dose escalation), and to further evaluate how safe JNJ-89862175 is at the RP2Ds in Part 2 (dose expansion) in participants with advanced stage solid tumors.

Detailed Description

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Conditions

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Advanced-stage Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Participants may be randomized in Part 2
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JNJ-89862175

Participants will receive JNJ-89862175 in Part 1 to determine the recommended phase 2 doses (RP2Ds). Dose-escalation and de-escalation will be based on study evaluation team (SET) decision. In Part 2, participants will receive JNJ-89862175 at the RP2Ds determined in Part 1.

Group Type EXPERIMENTAL

JNJ-89862175

Intervention Type DRUG

JNJ-89862175 will be administered.

Interventions

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JNJ-89862175

JNJ-89862175 will be administered.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants must have histologically or cytologically confirmed, metastatic or unresectable solid tumor of lung adenocarcinoma, renal cell carcinoma (RCC): clear cell or papillary carcinoma, endometrioid ovarian cancer and endometrioid uterine carcinoma
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening
* Participants on study drug and for 4 months after the last dose of study drug must not breastfeed or be pregnant, not donate gametes (that is, eggs or sperms) or freeze for future use for the purposes of assisted reproduction and wear an external condom

Exclusion Criteria

* Active central nervous system (CNS) involvement unless clinically stable
* History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
* History of solid organ or hematologic stem cell transplantation
* Known allergies, hypersensitivity, or intolerance to excipients of JNJ-89862175
* Has prior or concurrent second malignancy (other than the disease under study) in which the natural history or treatment is likely to interfere with safety endpoints or efficacy of the study drug
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AdventHealth Orlando

Orlando, Florida, United States

Site Status RECRUITING

NEXT Oncology

Irving, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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89862175LUC1001

Identifier Type: OTHER

Identifier Source: secondary_id

2025-521407-52-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

89862175LUC1001

Identifier Type: -

Identifier Source: org_study_id