A Study of JNJ-87890387 for Advanced Solid Tumors (NCT06178614) | Clinical Trial Compass
RecruitingPhase 1
A Study of JNJ-87890387 for Advanced Solid Tumors
United States, France, Spain200 participantsStarted 2023-12-14
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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, …
What they're measuring
1
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
Timeframe: Up to first 21 days after administration of the first full treatment dose
2
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity