Recruiting
Phase 1

JNJ-89862175

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07223125

Conditions

Advanced-stage Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-89862175

Study Details

Brief summary:

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.

Conditions

Advanced-stage Solid Tumors

Study ID

NCT07223125

Start date

Oct 10, 2025

Status verified date

Aug, 2026

Completion date

Aug 15, 2028

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

360 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

JNJ-89862175

JNJ-89862175 will be administered.

Primary outcome measure

  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs) [ Time Frame: Up to 21 days ]
  • Part 1: Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to 2 years and 10 months ]
  • Part 2: Number of Participants with Adverse Events (AEs) by Severity at RP2D [ Time Frame: Up to 2 years and 10 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

NEXT Oncology

Recruiting

Irving, Texas, United States, 75039

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.