Study Sponsor: Normunity AccelCo, Inc.

Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center

Phase of Study: Phase I

Purpose of study: The purpose of the study is to test the safety and efficacy of the study drug NRM-823 either as a single drug, or in combination with Pembrolizumab. This is a First-In-Human (FIH) study, meaning this is the first time the study drug is being tested in humans. The study drug works by activating the body’s T-Cells (part of your immune system) to attack and destroy cancer cells. It works by attaching itself to a targeted protein located on cancer cells, and on a protein located on your body’s T-Cells. The drug acts like a bridge to bring the two cells closer together, activating the T-cells to kill the cancer cells.

Inclusion Criteria:

– Must be at least 18 years or older.

– Diagnosed (squamous or adenocarcinoma) Non-small cell lung cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Head and Neck Squamous Cell Cancer, Esophageal squamous cell carcinoma (ESCC), Esophageal adenocarcinoma, Gastric/GEJ adenocarcinoma, Cervical, Endometrial, or Ovarian cancer that is advanced or metastatic.

– Must be able to provide archival tissue prior to starting study in order to determine Ly6K expression.

– Is intolerant of, or has already received standard of care therapies. Each disease type will have its own criteria, and will be discussed with your physician.

– Must have an ECOG of 0 – 1.

– Must have measurable disease per RECIST 1.1.

– Must have adequate organ function per local lab tests.

– Female participants of childbearing potential must have negative serum pregnancy test within 3 days prior to first dose.

– Patients must agree to highly effective forms of contraception, and must not donate sperm or eggs during the treatment period and for 6 months after the last dose administered.

*Additional inclusion criteria may apply and will be discussed with the physician and research team.

Exclusion Criteria:

– Has received prior approved or investigational TCE (T-Cell engager) or CAR-T therapy.

– Has received chemo, checkpoint inhibitors, biologic anticancer agents, or radiation therapy within 3 weeks prior to first dose of study drug.

– Has developed grade 2 or higher colitis or pneumonitis with prior therapy, or has had to stop therapy due to immune-related side effects.

– Has a history of pneumonitis requiring steroids.

– History of autoimmune disease (exceptions are psoriasis, alopecia, well-controlled hypothyroidism, or decreased adrenal function).

– Has received small-molecule inhibitors, hormonal agents, or bone only radiation within 14 days prior to first dose of NRM-823.

– Must have resolved any toxicities from prior therapy before starting study drug (alopecia is an exception).

– Has had a live vaccine within 14 days prior to first dose.

– Has had a major surgery within 4 weeks, or minor surgery within 2 weeks, prior to first dose of study drug.

– Has significant cardiac disease or condition.

– Has uncontrolled active infection (such as Hepatitis B or C infection, HIV-positive)

– Received a solid organ or bone marrow transplant

– Is pregnant or breastfeeding

*Additional exclusion criteria may apply and will be discussed with the physician and research team.

Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com  

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