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NCT Number: NCT07223125

A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors

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.

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Key information

Conditions

Advanced-stage Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Leon Berard, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-89862175

Drug

JNJ-89862175 will be administered.

Primary outcomes

  1. Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)

    Time frame: 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.

  2. Part 1: Number of Participants with Adverse Events (AEs) by Severity

    Time frame: 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.

  3. Part 2: Number of Participants with Adverse Events (AEs) by Severity at RP2D

    Time frame: 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 outcomes

  1. Objective Response Rate (ORR)

    Time frame: 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.

  2. Progression Free Survival (PFS)

    Time frame: 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.

  3. Duration of Response (DOR)

    Time frame: 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.

  4. 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

    Serum samples will be analyzed to determine Cmax of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite.

  5. 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

    Ctrough of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported.

  6. 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

    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.

  7. 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

    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.

  8. Accumulation Ratio of 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 with total and conjugated antibody, free payload and major metabolite will be reported.

  9. Number of Participants With Anti JNJ-89862175 Antibodies

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Oct 31, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.