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Monoclonal Antibodies
JNJ-87890387 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening
Have histologically or cytologically confirmed, metastatic, or unresectable solid tumor of specific 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years 9 months
Awards & highlights
Study Summary
This trial aims to find the recommended dose of a drug called JNJ-87890387 and to assess its safety.
Who is the study for?
This trial is for individuals with advanced solid tumors. Specific eligibility criteria are not provided, but typically participants must have a measurable disease and be in good general health.Check my eligibility
What is being tested?
The study is testing the safety and appropriate dosage of a new medication called JNJ-87890387 for treating advanced solid tumors.See study design
What are the potential side effects?
Potential side effects of JNJ-87890387 are not detailed here, but common ones may include fatigue, nausea, skin reactions, or other drug-specific reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is one of the specified types and cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
Secondary outcome measures
Part 1 and Part 2: Accumulation Ratio of JNJ-87890387
Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387
Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387
+7 moreOther outcome measures
Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate
Part 1 and Part 2: Time to Response (TTR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: JNJ-87890387Experimental Treatment1 Intervention
In Part 1 (Dose escalation) participants will receive JNJ-87890387. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. In Part 2 (Dose expansion), participants will receive JNJ-87890387 at the RP2D regimen(s) determined in Part 1.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,954 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,532 Total Patients Enrolled
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