Recruiting NCT07223125
A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JNJ-89862175.
- Who it may be relevant to
- Registry conditions: Advanced-stage Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Study of JNJ-89862175, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 Antibody Drug Conjugate, for Advanced Solid Tumors
Overview
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
- Drug JNJ-89862175
JNJ-89862175 will be administered.
Primary outcome measures
- Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs) [Time frame: Up to 21 days]
- Part 1: Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to 2 years and 10 months]
- Part 2: Number of Participants with Adverse Events (AEs) by Severity at RP2D [Time frame: Up to 2 years and 10 months]
Secondary outcome measures (9)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- AdventHealth Orlando — Orlando
- NEXT Oncology — Irving
France · 2 centers
- Centre Leon Berard — Lyon
- Gustave Roussy — Villejuif
South Korea · 2 centers
- Severance Hospital Yonsei University Health System — Seoul
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07223125 · 89862175LUC1001 · 89862175LUC1001 · 2025-521407-52-00