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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNormunity AccelCo, Inc.

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

Sponsors and collaborators