NCT07182149|RecruitingPhase 1FDA Drug

A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors

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

Normunity AccelCo, Inc.ClinicalTrials.gov

Compare

1 other identifier

NRM-823-101

Study Type

interventional

Target

150

Locations

1 country

Sites

Timeline

RegisteredSep 2025

StartedOct 2025

CompletionOct 2028

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P75+ for phase_1

Timeline

31mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach

1 country

9 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Progress17%

Oct 2025Oct 2028

First Submitted

Initial submission to the registry

September 11, 2025

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed

1 month until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

September 11, 2025

Last Update Submit

February 10, 2026

Conditions

Gastric Adenocarcinoma GEJ Adenocarcinoma Ovarian Cancer NSCLC Cervical Cancer Endometrial Cancer Triple Negative Breast Cancer (TNBC)HNSCC ESCC Esophageal Adenocarcinoma

Keywords

NRM-823

Outcome Measures

Primary Outcomes (2)

Incidence of treatment-emergent adverse events (TEAE)
Number of participants who experience treatment emergent AEs or SAEs
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.
From enrollment until 30 days post the last dose received by a participant

Study Arms (1)

NRM-823

EXPERIMENTAL

Administered per protocol requirements

Drug: NRM-823

Interventions

NRM-823DRUG

NRM-823 is a bispecific T-Cell Engager

NRM-823

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.