RecruitingPhase 1NCT06178614

A Study of JNJ-87890387 for Advanced Solid Tumors

A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors

Sponsor

Janssen Research & Development, LLC

Enrollment

200 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors Neoplasms

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria5

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

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