RecruitingInterventionalPhase 1

A Phase 1 Study of JNJ-89862175, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 Antibody Drug Conjugate, for Advanced Solid Tumors

NCT ID: NCT07223125Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

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.

Arms & interventions

DrugJNJ-89862175
JNJ-89862175 will be administered.

Outcome measures

Primary

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 days
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 months
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 months

Secondary

Objective Response Rate (ORR)
Time frame: Up to 2 years and 10 months
Progression Free Survival (PFS)
Time frame: Up to 2 years and 10 months
Duration of Response (DOR)
Time frame: Up to 2 years and 10 months
Maximum Plasma Concentration (Cmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)
Time frame: Up to 2 years and 10 months
Observed Plasma Concentration Immediately Before Next Dose Administration (Ctrough) of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)
Time frame: Up to 2 years and 10 months
Time to Reach Cmax (Tmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)
Time frame: Up to 2 years and 10 months
Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)
Time frame: Up to 2 years and 10 months
Accumulation Ratio of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)
Time frame: Up to 2 years and 10 months
Number of Participants With Anti JNJ-89862175 Antibodies
Time frame: Up to 2 years and 10 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (2)

AdventHealth Orlando

Orlando, Florida, 32803

Recruiting

NEXT Oncology

Irving, Texas, 75039

Recruiting