A Phase 1 Study of NM32-2668 (Anti-ROR1/Anti-CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients with Selected Advanced Solid Tumors

MC #24-01

NCT #
NCT06299163
Condition(s)
Anal Cancer, Breast Cancer, Gastric/GEJ Cancer, Leiomyosarcoma, liposarcoma, Lung Cancer (NSCLC), Mesothelioma, Ovarian/ Peritoneal/ Fallopian Tube Cancer, Skin Cancer/ Melanoma
Molecular Target(s)
CD3, HAS, ROR1
Drug Classification(s)
Antibody Drug Conjugate, Immunotherapy, Molecular Targeted Therapy
Agents(s)
NM32-2668
Phase(s)
I/II

Mechanism of Action

  • NM32-2668 is an anti-ROR1/Anti-CD3/Anti-HAS Tri-specific Antibody

Purpose

In this study, the sponsor and investigators want to learn:

  • How much of the study agent can be given with an acceptable level of side effects
  • The effects of the study agent (good and bad)
  • How much of the study agent is absorbed into the blood and how fast it is removed
  • If research tests can be used in the future to predict who will benefit from NM32-2668
  • How the study agent is acting on your body
  • If your body develops antibodies against the study agent which could reduce the amount of the study agent in your blood and the effects of the study agent on your disease

Study Design

Dose Escalation means that the amount of the study agent given will be increased in each group of research participants, to find the most appropriate dose for further study. You will be participating in this part of the study.

In the dose expansion part of the study, a larger number of people receive the study agent dose determined to be appropriate in the dose escalation part of the study. This part of the study is not yet open.

This is an open-label study. This means that you, the study doctor, study staff and the Sponsor will know the study agent and the doses that you are given.

If you decide to take part in the study, you will receive the study agent via IV (intravenous) infusion over 4 hours in cycles of 28 days. For the first cycle (Cycle 1) you will receive a total of 3 infusions each 7 days apart (on Days 1, 8 and 15). After Cycle 1, you will receive the study agent on the 1st and 15th day of each cycle, or just on the 1st day of each cycle. Your study doctor will inform you of your study treatment schedule.

In Cycle 1, after your first, second and third dose of study agent, you will stay in the hospital for at least 24 hours after your infusion has ended. The study doctor will provide additional information on how long you will stay in the hospital. After Cycle 1, you will be monitored by a qualified health professional during the infusions and for about 2 hours after the infusion has ended. Your study doctor may decide it is best for you to remain in the hospital if you have adverse effects after the infusions.

Location

Mary Crowley Cancer Research - Medical City Dallas

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