MC# 21-44 - A Phase I Study Investigating AGEN1777 as a Single-Agent and in Combination with PD-1 Inhibition in Patients with Advanced Solid Tumors

  • Agent(s): AGEN1777
  • Disease Type(s): Solid Tumor
  • Phase(s): I
  • Drug Classification(s): Targeted Therapy, Bispecific Antibodies
  • Molecular Target(s): TIGIT

Mechanism of Action

AGEN1777 is a TIGIT bispecific which targets an inhibitory receptor expressed on T and NK cells which may improve anti-tumor activity.

Purpose

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

  • How much of AGEN1777 can be given with an acceptable level of side effects
  • The effects of AGEN1777 (good and bad)
  • How much of AGEN1777 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 AGEN1777
  • Note: combination treatment with a PD-1 inhibitor is subsequently planned.  This trial description is only describing the single-agent dose escalation.
Inclusion Criteria
  • Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no acceptable standard therapy available or progressed on or after standard therapies
  • Measurable disease on baseline imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
  • Active infection requiring treatment
  • Lack of recovery for participants who had major surgical procedure within 4 weeks prior to first dose of protocol therapy
  • Clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ II), or serious uncontrolled cardiac arrhythmia
    requiring medication
  • QTc interval (corrected for heart rate using Fridericia’s formula prolongation) > 480 ms at Screening except for right bundle branch block
  • Patients with leptomeningeal metastases

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT05025085

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Re: MC# 21-44