A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGI Innovation, Inc.

About this trial

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-108, as a single agent, in patients with advanced or metastatic solid tumors

Eligibility criteria

Qualifiers

Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatoryguidelines) at the time of screening.

Has adequate organ and marrow function as defined in protocol.

Measurable disease as per RECIST v1.1.

ECOG performance status 0-1.

Disqualifiers

Has known active CNS metastases and/or carcinomatous meningitis. An active second malignancy.

Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.

Has active tuberculosis or has a known history of active tuberculosis. Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.

History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.

Trial design

Treatments tested in this trial

  • GI-108

Treatment groups

76 Participants
are divided into 1 treatment group

Sponsors and collaborators