A Study of JNJ-87890387 for Advanced Solid Tumors

NCT06178614 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CR10933987890387STM10012023-505358-16-00
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)

  Number of participants with DLTs will be reported. The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.

  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

  An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

  Up to 2 years 9 months

Secondary Outcomes (10)

• Part 1 and Part 2: Serum Concentration of JNJ-87890387

  Up to 2 years 9 months

• Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387

  Up to 2 years 9 months

• Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387

  Up to 2 years 9 months

• Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387

  Up to 2 years 9 months

• Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387

  Up to 2 years 9 months

Other Outcomes (2)

• Part 1 and Part 2: Time to Response (TTR)

  Up to 2 years 9 months

• Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate

  Up to 2 years 9 months

Study Arms (1)

JNJ-87890387

EXPERIMENTAL

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.

Drug: JNJ-87890387

Interventions

JNJ-87890387 DRUG

JNJ-87890387 will be administered.

JNJ-87890387

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (6)

Start Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): March 16, 2027
• Study Completion (Estimated): February 7, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (2); ES (2); US (2)