Recruiting

Phase 1

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

Sponsor:

Normunity AccelCo, Inc.

Code:

NCT07182149

Conditions

HNSCC

ESCC

Esophageal Adenocarcinoma

Gastric Adenocarcinoma

GEJ Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NRM-823

Study Details

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.

Conditions

HNSCC

ESCC

Esophageal Adenocarcinoma

Gastric Adenocarcinoma

GEJ Adenocarcinoma

Study ID

NCT07182149

Start date

Oct 30, 2025

Status verified date

Aug, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NRM-823

Administered per protocol requirements

Interventions

NRM-823

NRM-823 is a bispecific T-Cell Engager

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 ]
Incidence of dose-limiting toxicities (DLTs) [ Time Frame: From enrollment until 30 days post the last dose received by a participant ]

Central Contacts and Locations

Central contacts

Judy Schnyder, MBA

215-593-7119 judy.schnyder@normunity.com

Locations