A Phase I Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors

Study Identifier:
87890387STM1001
CT.gov Identifier:
NCT06178614
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-505358-16-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Neoplasms
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: JNJ-87890387
    • Read More
  • Drug: Intervention/treatment
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Neoplasms
    Solid Tumor