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First In-Human, Open-Label, Phase 1/2 Dose-Escalation with Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects with Advanced Solid Malignancies

Objective

Primary Objective Part A and B To characterize the safety and tolerability of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have a Food and Drug Administration (FDA) approval for anti-PD-1/PD-L1 therapy at time of recruitment. Primary Objectives Dose Expansion (Part B) To identify a recommended dose for future studies (RP2D) To assess the anti-tumor activity of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have FDA approval for anti-PD-1/PD-L1 therapy at time of recruitment

Protocol #

GIM122-CT01

Trial Phase:

Phase I/II

Principal Investigator:

Berkman, Jonathan

Cancer Type
  • Breast
  • Cervix
  • Corpus Uteri
  • Esophagus
  • Kidney
  • Lip
  • Oral Cavity and Pharynx
  • Liver
  • Lung
  • Melanoma
  • Skin
  • Other Digestive Organ
  • Other Female Genital
  • Other Skin
  • Stomach
Study Site
  • Virginia Commonwealth University

Subject must be >/= 18 years of age
Have a histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Faith McFadden, MSN, RN
    Phone: +1 804-628-0616
    Email Study Contact

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