Recruiting
Phase 1

JNJ-87890387

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06178614

Conditions

Neoplasms

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-87890387

Study Details

Brief 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).

Conditions

Neoplasms

Advanced Solid Tumors

Study ID

NCT06178614

Start date

Dec 14, 2023

Status verified date

Aug, 2026

Completion date

Feb 7, 2029

Anticipated

Primary completion date

Mar 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JNJ-87890387

In Part 1 (Dose escalation) participants will receive JNJ-87890387. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. In Part 2 (Dose expansion), participants will receive JNJ-87890387 at the RP2D regimen(s) determined in Part 1.

Interventions

JNJ-87890387

JNJ-87890387 will be administered.

Primary outcome measure

  • Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) [ Time Frame: Up to first 21 days after administration of the first full treatment dose ]
  • Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to 2 years 9 months ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Start Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

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.