JNJ-87890387 for Cancer

Recruiting at 6 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must not be taking: Immunotherapy

Disqualifiers: CNS involvement, Transplantation, Bowel obstruction, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and optimal dosage of a new cancer treatment called JNJ-87890387, an experimental therapy. It aims to assist individuals with certain advanced solid tumors, such as kidney, ovarian, uterine, colorectal, or lung cancer. Participants with these cancers who are willing to provide a tumor sample may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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-87890387 is likely to be safe for humans?

Research shows that JNJ-87890387, a new cancer treatment, is currently being tested. Lab studies have shown promising results in fighting tumors. However, limited information exists about its safety for humans. The current trial is in its early stages, focusing on finding a safe dose and identifying any side effects. Due to its early phase, little is known about how well people tolerate it. Participants in the trial will help researchers gather more information about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-87890387 because it represents a novel approach to cancer treatment. Unlike standard therapies like chemotherapy and targeted therapies that attack cancer cells broadly, JNJ-87890387 is designed to precisely target specific cancer pathways, potentially increasing effectiveness while minimizing side effects. This specificity could offer new hope for patients who don't respond well to existing treatments, providing a more tailored and potentially less toxic option.

What evidence suggests that JNJ-87890387 might be an effective treatment for cancer?

Research has shown that JNJ-87890387, the investigational treatment studied in this trial, holds promise for treating certain cancers. In lab studies, it effectively helped T-cells (a type of immune cell) attack cancer cells. This effect appeared in cancers like kidney and liver cancer, where the treatment targeted a specific protein called ENPP3 found on cancer cells. The treatment's ability to boost the immune system and kill cancer cells was demonstrated in both lab-grown cancer cells and real patient cancer samples. These early findings suggest that JNJ-87890387 could effectively treat cancers with high levels of the ENPP3 protein. ^{1 2 4 6 7}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors. Specific eligibility criteria are not provided, but typically participants must have a measurable disease and be in good general health.

Inclusion Criteria

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

My cancer is one of the specified types and cannot be removed by surgery.

My cancer can be measured or evaluated by medical tests.

Exclusion Criteria

I haven't been hospitalized for a bowel blockage in the last 30 days.

My brain metastases are stable, and I've been on low-dose steroids or none for 2 weeks.

My side effects from previous cancer treatments are mild, except for hair loss, skin changes, mild nerve damage, or hormone issues that are under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive JNJ-87890387 with dose escalation to determine the recommended phase 2 dose (RP2D)

Up to 21 days

Multiple visits for dose escalation and monitoring

Dose Expansion

Participants receive JNJ-87890387 at the RP2D regimen(s) determined in Part 1

Up to 2 years 9 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-87890387

Trial Overview The study is testing the safety and appropriate dosage of a new medication called JNJ-87890387 for treating advanced solid tumors.

How Is the Trial Designed?

Group I: JNJ-87890387 Experimental Treatment 1 Intervention

In Part 1 (Dose escalation) participants will receive JNJ-87890387. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. In Part 2 (Dose expansion), participants will receive JNJ-87890387 at the RP2D regimen(s) 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. 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06178614

A Study of JNJ-87890387 for Advanced Solid Tumors The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).

3. onclive.com onclive.com/view/dual-binding-xmab30819-shows-strong-specificity-in-enpp3-positive-rcc

Dual-Binding XmAb30819 Shows Strong Specificity in ... JNJ-87890387 led to potent ENPP3 specific in vitro T-cell activation, T-cell-mediated cytotoxicity, and proinflammatory cytokine release across ...

4. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/jnj-87890387-johnson-johnson-solid-tumor-likelihood-of-approval/

JNJ-87890387 by Johnson & Johnson for Solid Tumor JNJ-87890387 is under development for the treatment of advanced solid tumors including hepatocellular carcinoma, ovarian cancer, uterine cancer, ...

5. researchgate.net researchgate.net/publication/379619746_Abstract_LB122_JNJ-87890387_a_novel_ENPP3_bispecific_T-cell_redirector_ENPP3xCD3_with_tumor_selectivity_through_targeting_apical_surface_antigens

JNJ-87890387, a novel ENPP3 bispecific T-cell redirector ... In vitro, JNJ-87890387 demonstrated potent (pM) T-cell activation and cytotoxicity against tumor cell lines with different levels of endogenous ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/446015

A Study of JNJ-87890387 for Advanced Solid Tumors The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).

7. delta.larvol.com delta.larvol.com/Products/?ProductId=c9688e18-857d-4a8c-adbf-1146b8b37640

jnj-0387 / j&j - larvol delta JNJ-87890387, a novel ENPP3 bispecific T-cell redirector (ENPP3xCD3) with tumor selectivity through targeting apical surface antigens.