Cervical Cancer, Endometrial Cancer, ESCC, Esophageal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, HNSCC, NSCLC, Ovarian Cancer, Triple Negative Breast Cancer (TNBC)
Conditions
Keywords
NRM-823
Brief summary
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
DRUGNRM-823
NRM-823 is a bispecific T-Cell Engager
Sponsors
Normunity AccelCo, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAE) | From enrollment until 30 days post the last dose received by a participant | Number of participants who experience treatment emergent AEs or SAEs |
| Incidence of dose-limiting toxicities (DLTs) | From enrollment until 30 days post the last dose received by a participant | Number of participants who experience a DLT. A DLTs include protocol defined adverse events. |
Countries
United States
Contacts
CONTACTJudy Schnyder, MBA
STUDY_DIRECTORViviana Bozon, MD
Normunity AccelCo, Inc.
Outcome results
None listed