Trial Title:
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 in Patients With Advanced Solid Tumors
NCT ID:
NCT05824975
Condition:
Advanced Solid Tumor
Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
GI-102
CD80-IgG4 Fc-IL2 variant
Immunotherapy
IL-2
Interleukin-2
bispecific protein
immunocytokine
CD80
CTLA-4
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GI-102
Description:
Dose escalation phase:
GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 cycles).
Arm group label:
Dose escalation phase : GI-102 as a single agent
Intervention type:
Drug
Intervention name:
GI-102
Description:
Dose expansion phase:
GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 cycles).
Arm group label:
Dose expansion phase : GI-102 as a single agent
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory
guidelines) 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.
- Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other
prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1,
except alopecia and Grade 2 peripheral neuropathy.
- HIV infected patients must be on anti-retroviral therapy (ART) and have a
well-controlled HIV infection/disease as defined in protocol.
Key Exclusion Criteria:
- 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.
- Has an active autoimmune disease that has required systemic treatment in past 2
years.
- Previous immunotherapies related to mode of action of GI-102.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1
Day 1.
- Administration of prior systemic anti-cancer therapy including investigational
agents within 4 weeks prior to treatment.
- Radiotherapy within the last 2 weeks before start of study treatment administration,
with exception of limited field palliative radiotherapy.
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.
- Known hypersensitivity to any of the components of the drug products and/or
excipients of GI-102.
Other protocol defined inclusion exclusion criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mahesh Seetharam
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yujie Zhao
Facility:
Name:
Mayo Clinic in Minnesota
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jian Li Campian, PhD.
Facility:
Name:
Memorial Sloan-Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Viswatej Avutu, MD
Investigator:
Last name:
Viswatej Avutu, MD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wen Wee Ma, M.B.B.S
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seock-Ah Im, M.D., Ph.D.
Investigator:
Last name:
Seock-Ah Im, M.D., Ph.D.
Email:
Principal Investigator
Facility:
Name:
Yonsei University Health System, Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Byoung Chul Cho, M.D., Ph.D.
Investigator:
Last name:
Byoung Chul Cho, M.D., Ph.D.
Email:
Principal Investigator
Facility:
Name:
Yonsei University Health System, Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jung-Yun Lee, M.D., Ph.D.
Investigator:
Last name:
Jung-Yun Lee, M.D., Ph.D.
Email:
Principal Investigator
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jae Lyun Lee, M.D., Ph.D.
Investigator:
Last name:
Jae Lyun Lee, M.D., Ph.D.
Email:
Principal Investigator
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seung Tae Kim, M.D., Ph.D.
Investigator:
Last name:
Seung Tae Kim, M.D., Ph.D.
Email:
Principal Investigator
Facility:
Name:
St. Vincent's Hospital
Address:
City:
Suwon
Zip:
12647
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Byoung Yong Shim, M.D., Ph.D.
Investigator:
Last name:
Byoung Yong Shim, M.D., Ph.D.
Email:
Principal Investigator
Start date:
May 30, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
GI Innovation, Inc.
Agency class:
Industry
Source:
GI Innovation, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05824975
