About this trial

This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 design

Treatments tested in this trial

  • NRM-823

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

9
Colorado
Normunity Investigational Site80220, Denver United States
Connecticut
Normunity Investigational Site06519, New Haven United States
Minnesota
Normunity Investigational Site55425, Minneapolis United States
Ohio
Normunity Investigational Site43537, Maumee United States

Sponsors and collaborators

Normunity AccelCo, Inc.

Lead sponsor