A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NRM-823.
- Who it may be relevant to
- Registry conditions: HNSCC, ESCC, Esophageal Adenocarcinoma, Gastric Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.
Detailed description
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.
Interventions
- Drug NRM-823
NRM-823 is a bispecific T-Cell Engager
Primary outcome measures
- Incidence of treatment-emergent adverse events (TEAE) [Time frame: From enrollment until 30 days post the last dose received by a participant]
- Incidence of dose-limiting toxicities (DLTs) [Time frame: From enrollment until 30 days post the last dose received by a participant]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Normunity Investigational Site — Denver
- Normunity Investigational Site — New Haven
- Normunity Investigational Site — Minneapolis
- Normunity Investigational Site — Maumee
- Normunity Investigational Site — Philadelphia
- Normunity Investigational Site — Nashville
- Normunity Investigational Site — Dallas
- Normunity Investigational Site — San Antonio
- … and 1 more center
Identifiers
NCT: NCT07182149 · NRM-823-101