JNJ-70218902 for Advanced Stage Cancer

Not currently recruiting at 14 trial locations

Overseen By Study Contact

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: GnRH analogs

Must not be taking: Anticancer treatments

Disqualifiers: Brain metastases, Transplantation, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called JNJ-70218902 for individuals with advanced prostate cancer that has spread and no longer responds to standard hormone therapy or chemotherapy. The aim is to determine a safe and effective dose for future studies. The trial consists of two parts: the first tests increasing doses to identify the optimal one, and the second focuses on the safety of that chosen dose. This trial may suit those diagnosed with metastatic castration-resistant prostate cancer (mCRPC) who have not found success with other treatments. As a Phase 1 trial, this research seeks to understand 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 requires that if you are on gonadotropin-releasing hormone therapy, you must continue it throughout the study. For other medications, the protocol does not specify if you need to stop them.

Is there any evidence suggesting that JNJ-70218902 is likely to be safe for humans?

Research shows that JNJ-70218902 is in the early stages of testing to determine the safest dose for people with advanced cancer. Doctors are still assessing how much of the drug can be taken without causing serious side effects. As a new treatment, limited information exists on how well people tolerate it. In studies like this, participants might experience side effects as doctors work to find the right dose. The goal is to ensure the treatment is safe enough to advance to the next testing stage. Reaching this phase suggests some initial belief in its potential safety, but more evidence is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for metastatic castration-resistant prostate cancer (mCRPC), which often involve hormone therapies and chemotherapy, JNJ-70218902 is designed to work differently by targeting specific pathways involved in cancer cell growth. Researchers are excited about JNJ-70218902 because it has a novel mechanism of action that could potentially overcome resistance to current therapies. This unique approach might offer new hope for patients whose cancer has progressed despite conventional treatments, providing a fresh avenue for tackling advanced-stage cancer.

What evidence suggests that JNJ-70218902 might be an effective treatment for advanced stage cancer?

Research shows that JNJ-70218902 is a promising new treatment for advanced prostate cancer that no longer responds to standard hormone therapy. Early lab studies indicate that JNJ-70218902 attaches to cancer cells, aiding the immune system in attacking and destroying them. This method aims to enhance the body's natural ability to fight cancer. Participants in this trial will receive JNJ-70218902, with the study including a dose escalation phase to determine the optimal dose, followed by a dose expansion phase. Although detailed information from human trials remains limited, these initial results offer hope for effectively treating advanced prostate cancer. ^{1 3 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 adults with advanced solid tumors, specifically metastatic castration-resistant prostate cancer. Participants must have a good performance status (able to carry out daily activities), proper organ function, and if applicable, ongoing hormone therapy. They should have tried at least one prior cancer treatment but can't join if they still have significant side effects from past treatments or certain serious health conditions.

Inclusion Criteria

I am on GnRH therapy and started it before the study drug.

I am fully active or can carry out light work.

My cancer can be measured or seen on tests.

Exclusion Criteria

I am not currently using any other cancer treatments or experimental drugs.

I have cancer that has spread to my brain.

Side effects from my previous cancer treatments have mostly gone, except for hair loss or skin color changes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1: Dose Escalation

Participants receive JNJ-70218902 with dose levels escalated sequentially to determine the recommended Phase 2 Dose (RP2D)

21 days

Treatment - Part 2: Dose Expansion

Participants receive JNJ-70218902 at the RP2D determined in Part 1

Up to 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-70218902

Trial Overview The study is testing JNJ-70218902 to find the safest and most effective dose for Phase 2 trials. Part 1 of the study will determine the maximum tolerated dose and Part 2 will assess safety at this recommended dose in participants with advanced stage solid tumors.

How Is the Trial Designed?

Group I: Part 2: Dose Expansion Experimental Treatment 1 Intervention

Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.

Group II: Part 1: Dose Escalation Experimental Treatment 1 Intervention

Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39832129/

A first-in-human study of JNJ-70218902, a bispecific T-cell ... Metastatic castration-resistant prostate cancer (mCRPC) has a poor prognosis, necessitating the investigation of novel treatments and targets.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04397276

NCT04397276 | A Study of JNJ-70218902 in Participants ... JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06788509?term=appendix+cancer

A Rollover Study for Continued Study Treatment and ... Participants from the parent study (70218902EDI1001 [NCT04397276]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally.

4. withpower.com withpower.com/trial/phase-1-6-2020-acfdf

JNJ-70218902 for Advanced Stage Cancer This trial is testing JNJ-70218902, a drug that helps the immune system target and destroy cancer cells, in adult men with advanced prostate cancer that doesn't ...

5. researchgate.net researchgate.net/publication/388197664_A_first-in-human_study_of_JNJ-70218902_a_bispecific_T-cell-redirecting_antibody_against_TMEFF2_in_metastatic_castration-resistant_prostate_cancer

A first-in-human study of JNJ-70218902, a bispecific T-cell ... This study evaluated JNJ-70218902 (JNJ-902), a T-cell redirector targeting transmembrane protein with epidermal growth factor-like and 2 follistatin-like ...

6. academic.oup.com academic.oup.com/oncolo/article/30/1/oyae313/7964589

A first-in-human study of JNJ-70218902, a bispecific T-cell ... Metastatic castration-resistant prostate cancer (mCRPC) has a poor prognosis, necessitating the investigation of novel treatments and targets.

7. delta.larvol.com delta.larvol.com/Products/?ProductId=6016e768-db53-42da-b617-2f25f9a0f51e

JNJ-8902 / J&J, Genmab A first-in-human study of JNJ-70218902, a bispecific T-cell-redirecting antibody against TMEFF2 in metastatic castration-resistant prostate cancer. (PubMed ...