A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
NCT ID: NCT07182149
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2025-10-30
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NRM-823
Administered per protocol requirements
NRM-823
NRM-823 is a bispecific T-Cell Engager
Interventions
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NRM-823
NRM-823 is a bispecific T-Cell Engager
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Normunity AccelCo, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Melinda Merchant, MD, PhD
Role: STUDY_DIRECTOR
Normunity AccelCo, Inc.
Locations
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Normunity Investigational Site
Nashville, Tennessee, United States
Normunity Investigational Site
San Antonio, Texas, United States
Normunity Investigational Site
Fairfax, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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NRM-823-101
Identifier Type: -
Identifier Source: org_study_id