RecruitingInterventionalPhase 1

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

NCT ID: NCT07182149Sponsor: Normunity AccelCo, Inc.Last updated: 2026-02-12

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.

Arms & interventions

DrugNRM-823
NRM-823 is a bispecific T-Cell Engager

Outcome measures

Primary

Incidence of treatment-emergent adverse events (TEAE)
Number of participants who experience treatment emergent AEs or SAEs
Time frame: From enrollment until 30 days post the last dose received by a participant
Incidence of dose-limiting toxicities (DLTs)
Number of participants who experience a DLT. A DLTs include protocol defined adverse events.
Time frame: From enrollment until 30 days post the last dose received by a participant

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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.