HNSCCPhase 1NCT07182149
A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
A Phase 1 study testing NRM-823 in people with HNSCC and ESCC, run by Normunity AccelCo, Inc. at 18 sites in United States.
Trial summary
This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC, ESCC, Esophageal Adenocarcinoma
- What is being tested?
- NRM-823
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 18 sitesUnited States
- Study dates
- 30 Oct 2025to 31 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
Normunity Investigational Site
Boston, Massachusetts, 02114
- Recruiting
Normunity Investigational Site
Boston, Massachusetts, 02215
- Recruiting
Normunity Investigational Site
Charleston, South Carolina, 29425
- Recruiting
Normunity Investigational Site
Dallas, Texas, 75230
- Recruiting
Normunity Investigational Site
Denver, Colorado, 80220
- Recruiting
Normunity Investigational Site
Fairfax, Virginia, 22031
- Recruiting
Normunity Investigational Site
Hackensack, New Jersey, 07601
- Recruiting
Normunity Investigational Site
Houston, Texas, 77030
- Recruiting
Normunity Investigational Site
Maumee, Ohio, 43537
- Recruiting
Normunity Investigational Site
Minneapolis, Minnesota, 55425
- Recruiting
Normunity Investigational Site
Nashville, Tennessee, 37203
- Recruiting
Normunity Investigational Site
New Haven, Connecticut, 06519
- Recruiting
Normunity Investigational Site
Oklahoma City, Oklahoma, 73104
- Recruiting
Normunity Investigational Site
Philadelphia, Pennsylvania, 19107
- Recruiting
Normunity Investigational Site
Philadelphia, Pennsylvania, 19111
- Recruiting
Normunity Investigational Site
San Antonio, Texas, 78229
- Recruiting
Normunity Investigational Site
St Louis, Missouri, 63108
- Recruiting
Normunity Investigational Site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.
Read the detailed description
Part A of the study will evaluate the safety and tolerability of NRM-823. Part B of the study will further evaluate the safety and tolerability of NRM-823 of the recommended dose identified in PART A in an expansion cohort. Part C will evaluate the addition of a checkpoint inhibitor to NRM-823.
- Conditions
- HNSCC, ESCC, Esophageal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Ovarian Cancer
- Being tested
- NRM-823
- Keywords
- NRM-823
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Adenocarcinoma Of Esophagus, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRM-823Drug
NRM-823 is a bispecific T-Cell Engager
| Study group | Role | What they receive |
|---|---|---|
| NRM-823 | Experimental | Administered per protocol requirements Receives: Drug: NRM-823 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAE)
Number of participants who experience treatment emergent AEs or SAEs
Measured: From enrollment until 30 days post the last dose received by a participant
Incidence of dose-limiting toxicities (DLTs)
Number of participants who experience a DLT. A DLTs include protocol defined adverse events.
Measured: From enrollment until 30 days post the last dose received by a participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start30 Oct 2025
- Primary completion30 May 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Normunity AccelCo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Viviana Bozon, MD, Study director, Normunity AccelCo, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182149
- Sponsor's protocol ID
- NRM-823-101
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT07182149
- Acronym / sponsor ID
- NRM-823-101
- Conditions
- HNSCC, ESCC, Esophageal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Ovarian Cancer
- Keywords
- NRM-823
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Normunity AccelCo, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 A of the study will evaluate the safety and tolerability of NRM-823. Part B of the study will further evaluate the safety and tolerability of NRM-823 of the recommended dose identified in PART A in an expansion cohort. Part C will evaluate the addition of a checkpoint inhibitor to NRM-823.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRM-823 | Experimental | Drug: NRM-823Administered per protocol requirements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRM-823NRM-823 is a bispecific T-Cell Engager | Drug | NRM-823 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAE)
Time frame: From enrollment until 30 days post the last dose received by a participant
Number of participants who experience treatment emergent AEs or SAEs
Incidence of dose-limiting toxicities (DLTs)
Time frame: From enrollment until 30 days post the last dose received by a participant
Number of participants who experience a DLT. A DLTs include protocol defined adverse events.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viviana Bozon, MD study director
Normunity AccelCo, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NRM-823 in people with HNSCC and ESCC, run by Normunity AccelCo, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judy Schnyder, MBA (215-593-7119, judy.schnyder@normunity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAE) (time frame: From enrollment until 30 days post the last dose received by a participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.