A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors

Phase 1RecruitingNCT07182149

Normunity AccelCo, Inc.150 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

HNSCC ESCC Esophageal Adenocarcinoma Gastric Adenocarcinoma GEJ Adenocarcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.