Advanced Solid TumorPhase 1/2NCT07172802
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
A Phase 1/2 study testing GI-108 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by GI Innovation, Inc. at 3 sites in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor, Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- GI-108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 22 Apr 2025to Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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 steroidtherapy or any other form of immunosuppressive medications within 2 weeksprior to Cycle 1 Day 1.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, 03722
Byoung Chul Cho, MD, PhD, +82-2-2228-0880, cbc1971@yuhs.ac
- Recruiting
Asan Medical Center
Seoul, 05505
Dae Ho Lee, MD, PhD, leedaeho@amc.seoul.kr
- Recruiting
Samsung Medical Center
Seoul, 06351
Joon Oh Park, MD, PhD, +82-2-3410-3457, oncopark@skku.edu
About this study
Official title: An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
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
Read the detailed description
This is an open-label, multicenter, dose escalation and expansion, phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of GI-108 as a single agent in advanced or metastatic solid tumors. A control arm is not included.
The study is composed of two phases:
- Dose escalation phase
- Dose expansion phase The dose escalation phase will enroll up to 62 patients with advanced or metastatic solid tumors. At least 3 dose-limiting toxicity (DLT) evaluable patients will be enrolled in each cohort during the dose escalation to establish a maximum tolerated dose (MTD) or tentative recommended phase 2 dose (RP2D). Enrollment in each cohort may be extended to enroll additional 4~7 patients (aiming to recruit up to 10 patients including DLT evaluable patients per cohort), potentially enriched in certain tumor types and/or characteristics to confirm safety, PK and/or pharmacodynamics (PD) of GI-108. The Safety Monitoring Committee (SMC) will determine extension of each cohort based on the review of all available clinical data including efficacy, safety, PK and/or PD. Of the 7 planned cohorts in the dose escalation phase, up to 5 cohorts may be extended to include additional patients based on safety, efficacy PK and/or PD data. The evidence of enrollment extension should be documented for each cohort during dose escalation phase.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Non-small Cell Lung Cancer (NSCLC), Head and Neck (HNSCC), Pancreatic Cancer, Renal Cell Carcinoma (RCC)
- Being tested
- GI-108
- Keywords
- GI-108
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Pancreatic Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI-108Drug
Dose level will be escalated from 0.1mg/kg to 1.5 mg/kg and Recommended phase 2 dose (or RP2D) of GI-108 will be administered via IV infusion Q3W upto 2 years (approximately 35 cycles)
| Study group | Role | What they receive |
|---|---|---|
| GI-108 | Experimental | Dose escalation: GI-108 intravenous (IV), multiple ascending doses Dose optimization: GI-108 intravenous (IV), sRP2D Receives: Drug: GI-108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs) (Dose escalation phase)
Number and proportion of subjects experiencing DLTs during dose escalation, used to determine MTD and/or RP2D.
Measured: Study Day 1, assessed up to DLT period (3 weeks after treatment)
Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose escalation phase)
Number and proportion of subjects with immune-related AEs, graded per CTCAE v5.0.
Measured: From Day 1 through study completion (up to ~24 months)
Objective Response Rate (ORR) according to RECIST version 1.1 (Dose expansion phase)
Based on Investigator review of radiographic imaging
Measured: Study Day 1, assessed up to approximately 24 months
Secondary outcomes (11)
Objective Response Rate (ORR) according to RECIST version 1.1 (Dose escalation phase)
Based on Investigator review of radiographic imaging
Measured: Study Day 1, assessed up to approximately 24 months
Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose expansion phase)
Number and proportion of subjects with immune-related AEs, graded per CTCAE v5.0.
Measured: Day 1 through study completion, up to ~24 months
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have achieved CR, PR and stable disease (SD), per RECIST v1.1 guideline as determined by the investigators.
Measured: Study Day 1, assessed up to approximately 24 months
Duration of objective response (DoR)
DCR is defined as the time from the first occurrence of a documented objective response to the time of the first document disease progression or death from any cause, whichever occurs first, per RECIST v1.1 as determined by the investigator.
Measured: Study Day 1, assessed up to approximately 24 months
Progression-free survival (PFS)
PFS is defined as the time from the first study treatment (Day 1) to the first occurrence of progression or death from any cause, whichever occurs first, per RECIST v1.1 guideline as determined by the investigator
Measured: 6-month, 12-month, and 18-month
Overall survival (OS)
OS is defined as the time from the first study treatment to death from any cause
Measured: 12-month and 18-month
Peak plasma concentration (Cmax) of GI-108
Based on the concentration vs time profile by dose level
Measured: Study Day 1, assessed up to approximately 24 months
Half-life of GI-108 (T1/2)
Based on the concentration vs time profile by dose level
Measured: Study Day 1, assessed up to approximately 24 months
Area under the plasma concentration versus time curve (AUC) of GI-108
Based on the concentration vs time profile by dose level
Measured: Study Day 1, assessed up to approximately 24 months
Clearance of GI-108
Based on the concentration vs time profile by dose level
Measured: Study Day 1, assessed up to approximately 24 months
Volume of distribution (Vd) of GI-108 after administration
Based on the concentration vs time profile by dose level
Measured: Study Day 1, assessed up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start22 Apr 2025
- Primary completionFeb 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GI Innovation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172802
- Sponsor's protocol ID
- GII-108-P101
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07172802
- Acronym / sponsor ID
- GII-108-P101
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Non-small Cell Lung Cancer (NSCLC), Head and Neck (HNSCC), Pancreatic Cancer, Renal Cell Carcinoma (RCC)
- Keywords
- GI-108
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- GI Innovation, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is an open-label, multicenter, dose escalation and expansion, phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of GI-108 as a single agent in advanced or metastatic solid tumors. A control arm is not included.
The study is composed of two phases:
- Dose escalation phase
- Dose expansion phase The dose escalation phase will enroll up to 62 patients with advanced or metastatic solid tumors. At least 3 dose-limiting toxicity (DLT) evaluable patients will be enrolled in each cohort during the dose escalation to establish a maximum tolerated dose (MTD) or tentative recommended phase 2 dose (RP2D). Enrollment in each cohort may be extended to enroll additional 4~7 patients (aiming to recruit up to 10 patients including DLT evaluable patients per cohort), potentially enriched in certain tumor types and/or characteristics to confirm safety, PK and/or pharmacodynamics (PD) of GI-108. The Safety Monitoring Committee (SMC) will determine extension of each cohort based on the review of all available clinical data including efficacy, safety, PK and/or PD. Of the 7 planned cohorts in the dose escalation phase, up to 5 cohorts may be extended to include additional patients based on safety, efficacy PK and/or PD data. The evidence of enrollment extension should be documented for each cohort during dose escalation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GI-108 | Experimental | Drug: GI-108Dose escalation: GI-108 intravenous (IV), multiple ascending doses Dose optimization: GI-108 intravenous (IV), sRP2D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI-108Dose level will be escalated from 0.1mg/kg to 1.5 mg/kg and Recommended phase 2 dose (or RP2D) of GI-108 will be administered via IV infusion Q3W upto 2 years (approximately 35 cycles) | Drug | GI-108 |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs) (Dose escalation phase)
Time frame: Study Day 1, assessed up to DLT period (3 weeks after treatment)
Number and proportion of subjects experiencing DLTs during dose escalation, used to determine MTD and/or RP2D.
Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose escalation phase)
Time frame: From Day 1 through study completion (up to ~24 months)
Number and proportion of subjects with immune-related AEs, graded per CTCAE v5.0.
Objective Response Rate (ORR) according to RECIST version 1.1 (Dose expansion phase)
Time frame: Study Day 1, assessed up to approximately 24 months
Based on Investigator review of radiographic imaging
11 secondary outcomes
Objective Response Rate (ORR) according to RECIST version 1.1 (Dose escalation phase)
Time frame: Study Day 1, assessed up to approximately 24 months
Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose expansion phase)
Time frame: Day 1 through study completion, up to ~24 months
Disease Control Rate (DCR)
Time frame: Study Day 1, assessed up to approximately 24 months
Duration of objective response (DoR)
Time frame: Study Day 1, assessed up to approximately 24 months
Progression-free survival (PFS)
Time frame: 6-month, 12-month, and 18-month
Overall survival (OS)
Time frame: 12-month and 18-month
Peak plasma concentration (Cmax) of GI-108
Time frame: Study Day 1, assessed up to approximately 24 months
Half-life of GI-108 (T1/2)
Time frame: Study Day 1, assessed up to approximately 24 months
Area under the plasma concentration versus time curve (AUC) of GI-108
Time frame: Study Day 1, assessed up to approximately 24 months
Clearance of GI-108
Time frame: Study Day 1, assessed up to approximately 24 months
Volume of distribution (Vd) of GI-108 after administration
Time frame: Study Day 1, assessed up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GI-108 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by GI Innovation, Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hye Su Min, PhD (+82-2-404-2003, clinical-108@gi-innovation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (Dose escalation phase) (time frame: Study Day 1, assessed up to DLT period (3 weeks after treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.