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A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
NCT07182149 · Normunity AccelCo, Inc.
In plain English
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Official title
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
About this study
Part A of the study will evaluate the safety and tolerability of NRM-823. Part B of the study will further evaluate the safety and tolerability of NRM-823 of the recommended dose identified in PART A in an expansion cohort. Part C will evaluate the addition of a checkpoint inhibitor to NRM-823.
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.
Study design
Enrollment target: 150 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-30
Estimated completion: 2028-10-31
Last updated: 2026-02-12
Interventions
Drug: NRM-823
Primary outcomes
- • Incidence of treatment-emergent adverse events (TEAE) (From enrollment until 30 days post the last dose received by a participant)
- • Incidence of dose-limiting toxicities (DLTs) (From enrollment until 30 days post the last dose received by a participant)
Sponsor
Normunity AccelCo, Inc. · industry
Contacts & investigators
ContactJudy Schnyder, MBA · contact · judy.schnyder@normunity.com · 215-593-7119
InvestigatorViviana Bozon, MD · study_director, Normunity AccelCo, Inc.
All locations (9)
Normunity Investigational SiteRecruiting
Denver, Colorado, United States
Normunity Investigational SiteRecruiting
New Haven, Connecticut, United States
Normunity Investigational SiteRecruiting
Minneapolis, Minnesota, United States
Normunity Investigational SiteRecruiting
Maumee, Ohio, United States
Normunity Investigational SiteRecruiting
Philadelphia, Pennsylvania, United States
Normunity Investigational SiteRecruiting
Nashville, Tennessee, United States
Normunity Investigational SiteRecruiting
Dallas, Texas, United States
Normunity Investigational SiteRecruiting
San Antonio, Texas, United States
Normunity Investigational SiteRecruiting
Fairfax, Virginia, United States