Status:
RECRUITING
A Study of JNJ-87890387 for Advanced Solid Tumors
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 21 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06178614
Start Date
December 14 2023
End Date
July 21 2028
Last Update
December 5 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Start Midwest
Grand Rapids, Michigan, United States, 49546
2
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
3
Centre Leon Berard
Lyon, France, 69008
4
Institut Gustave Roussy
Villejuif, France, 94805