Overview
A Study of JNJ-87890387 for Advanced Solid Tumors
Status:
Recruiting
Recruiting
Trial end date:
2026-09-11
2026-09-11
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen Research & Development, LLC
Criteria
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