66 Participants NeededMy employer runs this trial

JNJ-1761981 for Cancer

Recruiting at 1 trial location
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Johnson & Johnson Enterprise Innovation Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best dose of JNJ-1761981, a new cancer treatment, by testing how much can be safely and effectively injected directly into tumors. In the first part, researchers will determine a safe dose, while the second part focuses on finding the right amount to target tumor lesions. This trial might suit individuals with advanced or metastatic solid tumors who have not found success with standard treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Is there any evidence suggesting that JNJ-1761981 is likely to be safe for humans?

Research on JNJ-1761981 remains in the early stages. Recent studies aim to find a dose that is safe and well-tolerated when administered directly into tumors. As these studies are just beginning, detailed information on side effects is limited. However, early trials typically focus on safety, so researchers will closely monitor and report any serious side effects.

In early trials, treatments often start with small doses. This approach allows researchers to observe the body's reactions and adjust the dosage if necessary. It is important to note that this treatment is not yet approved for general use. By participating in a trial, participants contribute to crucial research on its safety and effectiveness.12345

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about JNJ-1761981 because it offers a new approach to treating cancer by being administered directly into tumors, which could lead to more targeted effects. Unlike traditional chemotherapy that circulates throughout the body, this intratumoral delivery method aims to concentrate the treatment where it's needed most, potentially minimizing side effects. Additionally, there is an option for some patients to receive cetrelimab, a systemic therapy, which could enhance the overall effectiveness of the treatment. This combination of localized delivery and optional systemic therapy is what makes JNJ-1761981 stand out.

What evidence suggests that JNJ-1761981 might be an effective treatment for cancer?

Research on JNJ-1761981 remains in the early stages, so limited information exists about its effectiveness in treating cancer. In this trial, participants will receive JNJ-1761981 directly into tumors to target cancer cells more precisely. The goal is to shrink tumors or slow their growth. Although human studies have not yet provided much data, researchers find this treatment promising due to its potential direct impact on tumors. Early studies, including this trial, focus on identifying a dose that is both safe and effective. Further research is necessary to determine its efficacy against cancer.16789

Who Is on the Research Team?

J&

Johnson & Johnson Enterprise Innovation, Inc Clinical Trial

Principal Investigator

Johnson & Johnson Enterprise Innovation Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors (except brain tumors) who have tried standard treatments without success, can't tolerate them, or have no other options. Participants must be in good physical condition and use effective birth control during and after the study.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity only.
I use two highly effective birth control methods during and after the study.
I have metastatic adenocarcinoma or squamous cell carcinoma that got worse after standard treatment.
See 2 more

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to JNJ-1761981 or its excipients
I have active symptoms from cancer in my brain or spinal cord.
I do not have another cancer that could affect the study results or treatment safety.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants will receive JNJ-1761981 intratumorally to determine a safe and tolerable total dose

Up to 28 days

Dose Expansion

Participants in Cohort A will receive JNJ-1761981 at specified volumetric doses, with optional systemic therapy

Up to approximately 2 years 10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 2 years 10 months

What Are the Treatments Tested in This Trial?

Interventions

  • JNJ-1761981

Trial Overview

The study is testing different doses of a new drug called JNJ-1761981 injected directly into tumors. Some participants may also receive cetrelimab. The goal is to find safe and effective dose levels for treating solid tumors.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment2 Interventions
Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johnson & Johnson Enterprise Innovation Inc.

Lead Sponsor

Trials
5
Recruited
910+

Citations

A Study of JNJ-1761981 in Participants With Solid Tumors

The purpose of Part 1 of this study is to determine a safe, tolerable, and feasible recommended total dose of intratumorally administered JNJ-1761981.

A Study of JNJ-1761981 in Participants With Solid Tumors

Trial overview: A Study of JNJ-1761981 in Participants With Solid Tumors.

A Study of JNJ-1761981 in Participants With Solid Tumors

The purpose of Part 1 of this study is to determine a safe, tolerable, and feasible recommended total dose of intratumorally administered JNJ-1761981.

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