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A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
Trial Status: active
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
therapeutic activity of GI-102 as a single agent and in combination with conventional
anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of
advanced and/or metastatic solid tumors.
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
Additional locations may be listed on ClinicalTrials.gov for NCT05824975.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Approved
Name Not Available
This is a phase 1/2, open-label, dose-escalation and expansion study to evaluate the
safety, tolerability, and anti-tumor effect of GI-102 as a single agent and in
combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab
deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors. This study is
adaptive in nature.
The study is composed of four parts:
- Part A: Dose escalation and optimization phase of GI-102 intravenous (IV)
monotherapy
- Part A dose escalation phase
- Part A dose optimization phase: Dose optimization cohorts in patients with 2L+,
CPI-refractory metastatic melanoma
- Part B: Dose escalation and expansion phase of GI-102 subcutaneous (SC) monotherapy
- Part C: Indication specific cohorts of GI-102 IV in combination with conventional
anti-cancer drugs or trastuzumab deruxtecan (T-DXd)
- Part D: Indication specific cohorts of GI-102 IV in combination with pembrolizumab
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
