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

RecruitingPhase 1

Sponsor: Normunity AccelCo, Inc.

Conditions: HNSCC, ESCC, Esophageal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma

Interventions: NRM-823

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (18)

Denver, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
Maumee, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States