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New drug NRM-823 takes on Hard-to-Treat cancers

NCT ID NCT07182149

Disease control Sponsor: Normunity AccelCo, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This early-phase trial is testing a new drug called NRM-823, alone or with immunotherapy, in people with advanced solid tumors like lung, ovarian, or breast cancer that haven't responded to standard treatments. The study aims to see if the drug is safe and tolerable. About 150 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NRM-823 (a bispecific T-cell engager drug)
What this could lead to
If it works, this could point toward a new treatment option for several advanced cancers that have stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial, so the main goal is safety, not effectiveness. It may not work, and side effects could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric/GEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic. * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate liver, renal, pulmonary, and cardiac function. * Adequate hematologic function. Exclusion Criteria: * Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823 * History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy. * Has received an investigational therapy \<4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823. * With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus cervical cancer endometrial cancer endometrium neoplasm esophageal adenocarcinoma esophageal squamous cell carcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma non-small cell lung carcinoma ovarian cancer Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer Endometrial cancer ESCC Esophageal adenocarcinoma Gastric adenocarcinoma Gej adenocarcinoma HNSCC NSCLC Ovarian cancer Triple negative breast cancer (TNBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Normunity Investigational Site

    RECRUITING

    Denver, Colorado, 80220, United States

  • Normunity Investigational Site

    RECRUITING

    New Haven, Connecticut, 06519, United States

  • Normunity Investigational Site

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Normunity Investigational Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Normunity Investigational Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Normunity Investigational Site

    RECRUITING

    Minneapolis, Minnesota, 55425, United States

  • Normunity Investigational Site

    RECRUITING

    St Louis, Missouri, 63108, United States

  • Normunity Investigational Site

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Normunity Investigational Site

    RECRUITING

    Maumee, Ohio, 43537, United States

  • Normunity Investigational Site

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Normunity Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Normunity Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Normunity Investigational Site

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Normunity Investigational Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Normunity Investigational Site

    RECRUITING

    Dallas, Texas, 75230, United States

  • Normunity Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Normunity Investigational Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Normunity Investigational Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

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