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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 1

Conditions: Advanced-stage Solid Tumors

Treatments: Drug: JNJ-89862175

Study type: Interventional

Funder types: Industry

Identifiers

NCT07223125

2025-521407-52-00 (Registry Identifier)

89862175LUC1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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360 participants in 1 patient group

JNJ-89862175

Experimental group

Description:

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.

Treatment:

Drug: JNJ-89862175