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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) — Up to first 21 days after administration of the first full treatment dose Number of participants with DLTs will be reported. The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity — Up to 2 years 9 months An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Trial sites (6)
Facility
City
Region
Status
Start Midwest
Grand Rapids
Michigan
Recruiting
Sarah Cannon Research Institute
Nashville
Tennessee
Recruiting
Centre Leon Berard
Lyon
France
Recruiting
Institut Gustave Roussy
Villejuif
France
Recruiting
Hosp Univ Vall D Hebron
Barcelona
Spain
Recruiting
Hosp. Univ. 12 de Octubre
Madrid
Spain
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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