A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors
ConditionAdvanced-stage Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
The purpose of this study is to determine safe and effective dose (recommended phase 2 doses \[RP2Ds\]) of JNJ-89862175 in Part 1 (dose escalation), and to further evaluate how safe JNJ-89862175 is at the RP2Ds in Part 2 (dose expansion) in participants with advanced stage solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically or cytologically confirmed, metastatic or unresectable solid tumor of lung adenocarcinoma, renal cell carcinoma (RCC): clear cell or papillary carcinoma, endometrioid ovarian cancer and endometrioid uterine carcinoma
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening
Participants on study drug and for 4 months after the last dose of study drug must not breastfeed or be pregnant, not donate gametes (that is, eggs or sperms) or freeze for future use for the purposes of assisted reproduction and wear an external condom
Disqualifiers
Active central nervous system (CNS) involvement unless clinically stable
History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
History of solid organ or hematologic stem cell transplantation
Known allergies, hypersensitivity, or intolerance to excipients of JNJ-89862175
Trial design
Design model
Sequential
Treatments tested in this trial
JNJ-89862175
DrugJNJ-89862175 will be administered.
Treatment groups
360 Participants
are divided into 1 treatment groupGroup A: JNJ-89862175Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.
Time frame
Up to 21 days2
Part 1: Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. 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.
Time frame
Up to 2 years and 10 months3
Part 2: Number of Participants with Adverse Events (AEs) by Severity at RP2D
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. 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.
Time frame
Up to 2 years and 10 monthsSecondary outcomes
1
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have best overall response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v.) 1.1.
Time frame
Up to 2 years and 10 months2
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of JNJ-89862175 to either disease progression according to RECIST v. 1.1, or death due to any cause, whichever comes first.
Time frame
Up to 2 years and 10 months3
Duration of Response (DOR)
DOR is defined as the time from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST v. 1.1, or death due to any cause, whichever occurs first.
Time frame
Up to 2 years and 10 months4
Maximum Plasma Concentration (Cmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)
Serum samples will be analyzed to determine Cmax of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite.
Time frame
Up to 2 years and 10 monthsSponsors and contacts
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Source ClinicalTrials.gov