A Study of JNJ-87890387 for Advanced Solid Tumors

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Dec 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JNJ-87890387 for patients with advanced solid tumors, which are cancers that have spread and cannot be surgically removed. The main goals of the study are to find out the best doses of JNJ-87890387 for future trials and to learn more about its safety. The trial is currently looking for participants, including men and women aged 65 and older, who have specific types of cancers such as kidney cancer, ovarian cancer, uterine cancer, colorectal cancer, or lung cancer.

To be eligible, participants need to have a confirmed diagnosis of one of these cancers and measurable disease, meaning their cancer can be assessed with medical tests. They will also need to provide a sample of their tumor tissue for research. Participants should be in fairly good health, as indicated by their performance status. However, those with certain medical conditions, such as active brain cancer or severe reactions to previous cancer treatments, may not qualify. If someone joins the trial, they can expect to receive the study drug and undergo regular check-ups to monitor their health and any side effects. This is an important step in understanding how well this new treatment works and its safety for future patients.

Gender

ALL

Eligibility 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