JNJ-95437446 for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must not be taking: Systemic steroids

Disqualifiers: ILD, Pneumonitis, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

380 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, JNJ-95437446 (an experimental drug), to determine the best doses for individuals with advanced solid tumors, such as colorectal cancer. The focus is on assessing the safety and effectiveness of this drug before proceeding to further testing. The trial is open to those diagnosed with unresectable or advanced forms of non-small cell lung cancer, colorectal cancer, or head and neck cancer, who have undergone genetic testing for certain mutations. Participants should not have unresolved side effects from previous cancer treatments or recent serious infections. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications to join 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-95437446 is likely to be safe for humans?

Research has shown that JNJ-95437446 is being tested to determine the optimal dose for treating advanced solid tumors, such as colorectal cancer. As this is an early-stage study, detailed safety information remains limited. However, these initial trials aim to assess how well participants tolerate the treatment. Researchers will closely monitor for any side effects or adverse reactions while determining the appropriate dose. Participants in these trials typically receive close monitoring to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-95437446 for colorectal cancer because it offers a fresh approach compared to the usual treatments like chemotherapy and targeted therapies such as bevacizumab or cetuximab. Unlike these standard options, JNJ-95437446 is a novel compound that targets specific pathways involved in cancer cell growth and survival, potentially leading to more effective and less toxic outcomes. Its unique mechanism of action might provide new hope for patients who have not responded well to existing treatments.

What evidence suggests that JNJ-95437446 might be an effective treatment for colorectal cancer?

Research on JNJ-95437446 remains in the early stages. In this trial, participants will receive JNJ-95437446 to assess its potential against advanced solid tumors, such as colorectal cancer. JNJ-95437446 targets specific markers on cancer cells, potentially inhibiting their growth. While no human data currently demonstrates its effectiveness, scientists remain hopeful due to the drug's design. Current studies primarily focus on determining the appropriate dose and ensuring safety for participants. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced-stage solid tumors, specifically colorectal cancer. Participants must meet certain health criteria to be included but specific inclusion and exclusion details are not provided.

Inclusion Criteria

My lung or colorectal cancer has been tested for specific genetic changes.

My cancer can be measured or seen on tests.

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

Exclusion Criteria

I haven't had a serious infection needing treatment in the last week.

I have had lung inflammation or pneumonitis that needed treatment with steroids.

Side effects from my previous cancer treatment are mild or gone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive JNJ-95437446 to determine recommended phase 2 doses (RP2Ds)

Up to 21 days

Treatment Part 2

Participants receive JNJ-95437446 at the RP2Ds developed in Part 1

Up to 2 years and 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-95437446

Trial Overview The study is testing the safety and appropriate dosage levels of a new medication called JNJ-95437446. The first part of the trial will determine safe dosages, while the second part will assess safety at these doses in patients.

How Is the Trial Designed?

Group I: JNJ-95437446 Experimental Treatment 1 Intervention

Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed 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. clinicaltrials.gov clinicaltrials.gov/study/NCT07107230

A Study of JNJ-95437446 in Participants With Advanced- ... Participants with non-small cell lung cancer (NSCLC) adenocarcinoma and colorectal cancer (CRC) must have local molecular testing to determine epidermal growth ...

2. patlynk.com patlynk.com/trial/NCT07107230

JNJ-95437446 for Advanced Solid Tumors This study is important because it seeks to find a safer and more effective treatment option for patients whose cancer has progressed to an advanced stage, ...

3. withpower.com withpower.com/trial/phase-1-colorectal-neoplasms-6-2025-314c4

JNJ-95437446 for Colorectal Cancer The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in ...

4. healthscout.app healthscout.app/trial_match/view_trial/NCT07107230/?back=/trial_match/view_trials/condition/colon/%3Fpage%3D21

Trial: A Study of JNJ-95437446 in Participants… - HealthScout No clinical efficacy or safety results have been reported to date; this first-in-human study focuses on establishing RP2D(s) and characterizing safety, PK, ...

5. meddatax.com meddatax.com/clinical-trials/NCT07107230

A Study of JNJ-95437446 in Participants With Advanced ... The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of ...

6. trialx.com trialx.com/clinical-trials/listings/313701/a-study-of-jnj-95437446-in-participants-with-advanced-stage-solid-tumors/

A Study of JNJ-95437446 in Participants With Advanced ... The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the ...

7. adisinsight.springer.com adisinsight.springer.com/trials/700384886

A Phase 1 Study of JNJ-95437446 in Participants ... - AdisInsight The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of ...