150 Participants Needed

NRM-823 for Cancer

Recruiting at 2 trial locations
JS
Overseen ByJudy Schnyder, MBA
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 tests a new treatment called NRM-823 to determine its safety and effectiveness for people with advanced or metastatic solid tumors, which are cancers that have spread or grown in place. The focus includes various types of cancer, such as certain lung, breast, and esophageal cancers. Participants must have a diagnosis of one of these cancers and be in relatively good physical condition, with no recent treatments that could interfere with the 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 requires that you stop taking certain cancer treatments like chemotherapy, biologic agents, or radiation therapy at least 3 weeks before starting the study drug. However, it doesn't specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that NRM-823 is likely to be safe for humans?

Research is currently testing NRM-823 for safety in treating advanced solid tumors. In this early stage, researchers focus primarily on its safety and patient tolerance. Detailed information on side effects or negative reactions is not yet available. At this phase, the emphasis remains on how patients handle the treatment. If NRM-823 is well-tolerated and does not cause major side effects, it would mark a positive step in its development.12345

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments, which often involve chemotherapy or radiation, NRM-823 is unique because it targets cancer cells with a new mechanism of action. This innovative drug is designed to specifically interact with a particular protein found in cancer cells, potentially reducing harm to healthy cells and minimizing side effects. Researchers are excited about NRM-823 because it promises a more targeted approach, which could lead to more effective and less toxic cancer therapies.

What evidence suggests that NRM-823 might be an effective treatment for cancer?

Research shows that NRM-823, the treatment under study in this trial, has promising results in fighting cancer. Lab and animal studies have demonstrated its effectiveness in stopping tumor growth. This treatment uses T cells, part of the immune system, to attack cancer cells. Success in lab settings suggests it might help treat solid tumors in people. While these results are hopeful, further research is needed to confirm its effectiveness in cancer patients.12567

Who Is on the Research Team?

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Melinda Merchant, MD, PhD

Principal Investigator

Normunity AccelCo, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced or metastatic cancers, including lung, triple-negative breast, head and neck squamous cell, esophageal adenocarcinoma, stomach cancer, cervical cancer, endometrial cancer, and ovarian cancer. Participants must be in good physical condition (ECOG 0-1) and have proper liver, kidney, lung, heart function along with adequate blood counts.

Inclusion Criteria

My cancer is advanced or has spread, and it's one of the specified types.
I am fully active or restricted in physically strenuous activity but can do light work.
My liver, kidneys, lungs, and heart are all working well.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Evaluation of the safety and tolerability of NRM-823

Duration not specified

Treatment Part B

Further evaluation of safety and tolerability of NRM-823 at the recommended dose in an expansion cohort

Duration not specified

Treatment Part C

Evaluation of the addition of a checkpoint inhibitor to NRM-823

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NRM-823
Trial Overview The study tests the safety and effectiveness of a new medication called NRM-823 for treating various types of advanced solid tumors. It's an early-stage trial to determine if this drug can help people whose tumors are resistant to standard treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: NRM-823Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Normunity AccelCo, Inc.

Lead Sponsor

Citations

Normunity Doses First Patient in Phase 1 Trial of NRM-823, ...Preclinical data with NRM-823 has demonstrated potent anti-tumor activity in vitro and in vivo with T cell-mediated cytotoxicity in humanized ...
Normunity announces first patient dosed in Phase 1 clinical ...The trial is designed to evaluate the safety, tolerability and initial efficacy of NRM-823 in increasing dose levels as a monotherapy and in ...
A Phase 1 Study of NRM-823 in Participants With Locally ...This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors. Detailed Description. Part ...
Normunity announces first patient dosed in Phase 1 clinical ...Preclinical data with NRM-823 has demonstrated potent anti-tumor activity in vitro and in vivo with T cell-mediated cytotoxicity in humanized ...
A Phase 1 Study of NRM-823 in Participants With ... - MedPathThis study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.
Normunity Doses First Patient in NRM-823 Cancer TrialThe Phase 1 study is designed to assess the safety, tolerability, and preliminary efficacy of NRM-823 both as a monotherapy and in combination ...
Normunity Doses First Patient in Phase 1 Trial of NRM-823, ...The trial is designed to evaluate the safety, tolerability and initial efficacy of NRM-823 in increasing dose levels as a monotherapy and in ...
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