JNJ-89862175 for Cancer

Recruiting at 2 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Disqualifiers: CNS involvement, Cardiovascular disease, Transplantation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the safest and most effective dose of a new drug, JNJ-89862175 (experimental treatment), for advanced solid tumors. The focus includes cancers such as lung adenocarcinoma, certain kidney cancers, and specific types of ovarian and uterine cancer. Participants will initially help establish the correct dose and then further assess its safety at that dose. Individuals with these cancers, who do not have other major health issues, may be suitable for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that JNJ-89862175 is likely to be safe for humans?

Research shows that JNJ-89862175 is in the early stages of testing to determine the safest dose for people with advanced solid tumors. As a Phase 1 trial, information about its safety in humans remains limited. Phase 1 trials primarily assess a treatment's safety and identify the optimal dose. This marks the first time the treatment is tested in humans, so detailed information is scarce.

In early trials like this, researchers focus on observing side effects and assessing how well participants tolerate the treatment. Given the treatment's novelty, researchers closely monitor participants to ensure safety and adjust doses if necessary. This process helps them understand potential risks. Participants should consult the study team for more detailed information about the trial's safety aspects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-89862175 because it represents a fresh approach to cancer treatment. Unlike traditional therapies such as chemotherapy, which broadly attack both cancerous and healthy cells, JNJ-89862175 targets specific proteins involved in cancer cell growth. This precision could mean fewer side effects and potentially more effective treatment outcomes. Additionally, the novel mechanism might offer hope for patients with cancers resistant to current therapies, providing a new line of defense in the fight against cancer.

What evidence suggests that JNJ-89862175 might be an effective treatment for cancer?

Research has shown that JNJ-89862175 is being tested as a potential treatment for advanced solid tumors in this trial. Participants will receive JNJ-89862175 to determine the safest and most effective dose. Although limited information exists from human trials, the research focuses on the drug's ability to target and attack tumor cells. Early results suggest that the drug might help control tumor growth, making it a promising option for further cancer treatment studies. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors who are seeking new treatment options. Participants should be adults who have a measurable disease and can provide tissue samples. They must be able to take oral medication and have acceptable blood test results.

Inclusion Criteria

My cancer is a specific type that has spread and cannot be surgically removed.

I am fully active or restricted in physically strenuous activity but can do light work.

I will not breastfeed, be pregnant, donate gametes, or freeze them for assisted reproduction while on the study drug and for 4 months after.

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to excipients of JNJ-89862175

I have another cancer that might affect this study's safety or results.

My brain or spinal cord cancer is stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive JNJ-89862175 to determine the recommended phase 2 doses (RP2Ds) with dose-escalation and de-escalation based on study evaluation team decision

Up to 21 days

Dose Expansion

Participants receive JNJ-89862175 at the RP2Ds determined in Part 1 to further evaluate safety

Up to 2 years and 10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-89862175

Trial Overview

The study is testing JNJ-89862175, aiming to find the safest and most effective dose for treating advanced solid tumors. It has two parts: first, finding the right dose (dose escalation), then seeing how well it works at that dose (dose expansion).

How Is the Trial Designed?

Group I: JNJ-89862175 Experimental Treatment 1 Intervention

Participants will receive JNJ-89862175 in Part 1 to determine the recommended phase 2 doses (RP2Ds). Dose-escalation and de-escalation will be based on study evaluation team (SET) decision. In Part 2, participants will receive JNJ-89862175 at the RP2Ds determined in Part 1.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1.

withpower.com

withpower.com/trial/phase-1-advanced-stage-solid-tumors-9-2025-0705e

JNJ-89862175 for Cancer

Trial Overview The study is testing JNJ-89862175, aiming to find the safest and most effective dose for treating advanced solid tumors. It has two parts: first, ...

2.

clin.larvol.com

clin.larvol.com/trial-detail/NCT07223125

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

Serum samples will be analyzed to determine Cmax of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite. Up to 2 years and 10 ...

3.

ctv.veeva.com

ctv.veeva.com/study/a-study-of-jnj-89862175-for-treatment-of-advanced-solid-tumors

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

The purpose of this study is to determine safe and effective dose (recommended phase 2 doses [RP2Ds]) of JNJ-89862175 in Part 1 (dose ...

4.

oncologypipeline.com

oncologypipeline.com/apexonco/xencor-could-face-second-challenge-former-partner

Xencor could face second challenge from former partner

Last week an entry appeared on a listing of trials under way at AdventHealth Research Institute revealing a phase 1 study of JNJ-89862175, ...

5.

jnjmedicalconnect.com

jnjmedicalconnect.com/media/attestation/congresses/oncology/2024/aacr/jnj87890387-a-novel-enpp3-bispecific-tcell-redirector-enpp3xcd3-with-tumor-selectivity-through-targe.pdf

JNJ-87890387, A Novel ENPP3 Bispecific T-cell Redirector ...

In vivo, JNJ-87890387 demonstrated ENPP3-expression-dependent potent anti-tumor activity in multiple cell line-derived and patient tumor-derived RCC and HCC.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07223125

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

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) ...