Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Therapeutic Activity of GI-102 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Therapeutic Activity of GI-102 in Patients With Advanced Solid Tumors
Official Title: An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2a Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Therapeutic Activity of GI-102 in Patients With Advanced or Metastatic Solid Tumors
Study ID: NCT05824975
Study Description
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent over a range of advanced and/or metastatic solid tumors.
Detailed Description: This is a phase 1/2a, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, and anti-tumor effect of GI-102 as a single agent over a range of advanced and/or metastatic solid tumors. This study is adaptive in nature. While GI-102 is being investigated as a single agent in this trial, GI-102 has the potential of being combined with other agents. Based on the data from ongoing nonclinical studies and the dose escalation phase, additional combination therapies \[GI-102 + drug(s) X\] may be proposed and added to this study protocol via an amendment. This study will comprise two phases. * GI-102 monotherapy dose escalation phase * GI-102 monotherapy dose expansion phase GI-102 is a novel bi-specific Fc fusion protein containing the CD80 ectodomain as an N-terminal moiety and an interleukin (IL)-2 variant as a C-terminal moiety configurated via a human immunoglobulin G4 (IgG4) Fc. GI-102 has unique characteristics by having bispecificity to CD80 and IL2Rβγ. The CD80 portion is responsible for targeting tumor/immune cells while blocking CTLA-4 expressed on the Treg cells. The IL-2v of GI-102 is designed to abolish IL-2Rα affinity and therefore minimize the effect on Treg while it has very outstanding effect on NK and CD8 T cell proliferation and activity through IL-2Rbr affinity.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Mayo Clinic in Minnesota, Rochester, Minnesota, United States
Cleveland Clinic, Cleveland, Ohio, United States
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University Health System, Severance Hospital, Seoul, , Korea, Republic of
Yonsei University Health System, Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
St. Vincent's Hospital, Suwon, , Korea, Republic of
Contact Details
Name: Nari Yun, PhD
Affiliation: GI Innovation, Inc.
Role: STUDY_DIRECTOR
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