Advanced-stage Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUGJNJ-89862175
JNJ-89862175 will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants may be randomized in Part 2
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Has prior or concurrent second malignancy (other than the disease under study) in which the natural history or treatment is likely to interfere with safety endpoints or efficacy of the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs) | Up to 21 days | The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation. |
| Part 1: Number of Participants with Adverse Events (AEs) by Severity | Up to 2 years and 10 months | 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. |
| Part 2: Number of Participants with Adverse Events (AEs) by Severity at RP2D | Up to 2 years and 10 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 2 years and 10 months | 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. |
| Progression Free Survival (PFS) | Up to 2 years and 10 months | 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. |
| Duration of Response (DOR) | Up to 2 years and 10 months | 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. |
| Maximum Plasma Concentration (Cmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | Up to 2 years and 10 months | Serum samples will be analyzed to determine Cmax of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite. |
| Observed Plasma Concentration Immediately Before Next Dose Administration (Ctrough) of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | Up to 2 years and 10 months | Ctrough of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported. |
| Time to Reach Cmax (Tmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | Up to 2 years and 10 months | Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported. |
| Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | Up to 2 years and 10 months | AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported. |
| Accumulation Ratio of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite) | Up to 2 years and 10 months | Accumulation ratio of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported. |
| Number of Participants With Anti JNJ-89862175 Antibodies | Up to 2 years and 10 months | Serum samples will be analyzed for the detection of anti-JNJ-89862175 antibodies using a validated assay method. |
Countries
France, South Korea, United States
Contacts
CONTACTStudy Contact
Outcome results
None listed