Advanced Solid TumorPhase 1/2NCT05824975
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)
A Phase 1/2 study testing GI-102 subcutaneous (SC), GI-102 and doxorubicin in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by GI Innovation, Inc. at 11 sites in 2 countries.
Trial summary
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. 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, Soft Tissue Sarcoma (STS)
- What is being tested?
- GI-102 subcutaneous (SC), GI-102 and doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 30 May 2023to 24 Apr 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 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.
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.
Show all 14Show fewer
- 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
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
South Korea6 sites, 6 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 03080
Seock-Ah Im, MD, PhD
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, 03722
Byoung Chul Cho, MD, PhD
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, 03722
Jung-Yun Lee, MD, PhD
- Recruiting
Asan Medical Center
Seoul, 05505
Jae-Lyun Lee, MD, PhD
- Recruiting
Samsung Medical Center
Seoul, 06351
Seung Tae Kim, MD, PhD
- Recruiting
St. Vincent's Hospital
Suwon, suwon, 12647
Byoung Yong Shim, MD, PhD
United States5 sites, 5 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Wen Wee Ma, MBBS
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Yujie Zhao, MD, PhD
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Viswatej Avutu, MD
- Recruiting
Mayo Clinic in Minnesota
Rochester, Minnesota, 55905
Jian Li Campian, MD, PhD
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Mahesh Seetharam, MD
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-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)
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.
Read the detailed description
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 IL-2Rbr affinity.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC), Hepatocellular Carcinoma (HCC), Colorectal Cancer (CRC)
- Being tested
- GI-102 subcutaneous (SC), GI-102, doxorubicin, paclitaxel, bevacizumab
- Keywords
- GI-102, CD80-IgG4 Fc-IL2 variant, Immunotherapy, IL-2, Interleukin-2, bispecific protein, immunocytokine, CD80, CTLA-4, Pembrolizumab, T-DXd, Trastuzumab deruxtecan, Doxorubicin, Paclitaxel, Bevacizumab, Eribulin
- Medical subject headings
- Neoplasm Metastasis, Sarcoma, Carcinoma, Hepatocellular, Colorectal Neoplasms, Melanoma, Carcinoma, Renal Cell, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI-102 subcutaneous (SC)Drug
0.12 mg/kg, 0.24 mg/kg or Recommended phase 2 dose of GI-102 will be administered via SC injection Q3W up to 2 years (approximately 35 years).
GI-102Drug
Dose level will be escalated from 0.06 mg/kg to 0.45 mg/kg and Recommended phase 2 dose (or RP2D-1, RP2D+1) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
doxorubicinDrug
Doxorubicin will be administered intravenously at a dose of 75 mg/m2 on Day 3 every 3-week (21-day) cycle for up to 6 cycles.
paclitaxelDrug
Paclitaxel will be administered intravenously over 1 hour at a dose of 80 mg/m2 each time weekly as a diluted solution according to the prescribing information.
bevacizumabDrug
Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks.
eribulinDrug
Eribulin will be administered intravenously at a dose of over 1.4 mg/m2 over 2 to 5 minutes on Days 3 and 10 every 3-week (21-day) cycle.
trastuzumab deruxtecan (T-DXd)Drug
Also called ENHERTU®
T-DXd will be administered initially as a 5.4 mg/kg (or 6.4 mg/kg only for gastric cancer) IV over 30 - 90 minutes every 3 weeks.
pembrolizumabDrug
Also called KEYTRUDA®
pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
GI-102Drug
Recommended phase 2 dose (or RP2D-1, RP2D-2) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
| Study group | Role | What they receive |
|---|---|---|
| GI-102 | Experimental | Dose escalation: GI-102 intravenous (IV), multiple ascending doses Dose optimization: GI-102 intravenous (IV), sRP2D Dose optimization: GI-102 intravenous (IV), sRP2D-1 (or sRP2D+1) Receives: Drug: GI-102 |
| GI-102 subcutaneous (SC) | Experimental | Dose escalation: GI-102 subcutaneous (SC), multiple ascending doses Dose expansion: GI-102 subcutaneous (SC), sRP2D Receives: Drug: GI-102 subcutaneous (SC) |
| GI-102 + doxorubicin | Experimental | Not described Receives: Drug: doxorubicin; Drug: GI-102 |
| GI-102 + paclitaxel + bevacizumab | Experimental | Not described Receives: Drug: paclitaxel; Drug: bevacizumab; Drug: GI-102 |
| GI-102 + eribulin | Experimental | Not described Receives: Drug: eribulin; Drug: GI-102 |
| GI-102 + trastuzumab deruxtecan (T-DXd) | Experimental | Not described Receives: Drug: trastuzumab deruxtecan (T-DXd); Drug: GI-102 |
| GI-102 + pembrolizumab | Experimental | Not described Receives: Drug: pembrolizumab; Drug: GI-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B)
A DLT is defined as a clinically significant AE (classified according to the NCI CTCAE version 5) or significant laboratory abnormality that occur during the DLT assessment periods, during dose escalation and dose expansion, and is considered by the Investigator to be related to GI-102.
Measured: Study Day 1, assessed up to DLT period (3 weeks after treatment)
Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose escalation phase of Part A and B)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Study Day 1, assessed up to approximately 24 months
Objective Response Rate (ORR) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D)
ORR is defined as the percentage of participants with investigator-assessed objective response of complete response (CR) or partial response (PR). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Measured: Study Day 1, assessed up to approximately 24 months
Secondary outcomes (12)
Objective Response Rate (ORR) (dose escalation phase of Part A and B)
ORR is defined as the percentage of participants with investigator-assessed objective response of complete response (CR) or partial response (PR). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Measured: Study Day 1, assessed up to approximately 24 months
Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D)
A DLT is defined as a clinically significant AE (classified according to the NCI CTCAE version 5) or significant laboratory abnormality that occur during the DLT assessment periods, during dose escalation and dose expansion, and is considered by the Investigator to be related to GI-102.
Measured: Study Day 1, assessed up to DLT period (3 weeks after treatment)
Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Study Day 1, assessed up to approximately 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-102
Based on the concentration vs time profile by dose level
Measured: Study Day 1, assessed up to approximately 24 months
Half-life of GI-102 (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-102
Based on the concentration vs time profile by dose level
Measured: Study Day 1, assessed up to approximately 24 months
Clearance of GI-102
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-102 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 posted24 Apr 2023
- Study start30 May 2023
- Primary completion12 Nov 2025 (estimated)
- Study completion24 Apr 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
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GI Innovation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Nari Yun, PhD, Study director, GI Innovation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824975
- Sponsor's protocol ID
- GII-102-P101
- Other IDs
- KEYNOTE-G08, MK3475-G08
- Status last verified
- Nov 2024
- First submitted
- 28 Mar 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. 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-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)
- ClinicalTrials.gov ID
- NCT05824975
- Acronym / sponsor ID
- GII-102-P101
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC), Hepatocellular Carcinoma (HCC), Colorectal Cancer (CRC)
- Keywords
- GI-102, CD80-IgG4 Fc-IL2 variant, Immunotherapy, IL-2, Interleukin-2, bispecific protein, immunocytokine, CD80
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- GI Innovation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 30 May 2023 (actual)
- Primary completion
- 12 Nov 2025 (estimated)
- Study completion
- 24 Apr 2027 (estimated)
- First posted
- 24 Apr 2023 (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-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.
Detailed description
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 IL-2Rbr affinity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| GI-102 | Experimental | Drug: GI-102Dose escalation: GI-102 intravenous (IV), multiple ascending doses Dose optimization: GI-102 intravenous (IV), sRP2D Dose optimization: GI-102 intravenous (IV), sRP2D-1 (or sRP2D+1) |
| GI-102 subcutaneous (SC) | Experimental | Drug: GI-102 subcutaneous (SC)Dose escalation: GI-102 subcutaneous (SC), multiple ascending doses Dose expansion: GI-102 subcutaneous (SC), sRP2D |
| GI-102 + doxorubicin | Experimental | Drug: doxorubicin, Drug: GI-102 |
| GI-102 + paclitaxel + bevacizumab | Experimental | Drug: paclitaxel, Drug: bevacizumab, Drug: GI-102 |
| GI-102 + eribulin | Experimental | Drug: eribulin, Drug: GI-102 |
| GI-102 + trastuzumab deruxtecan (T-DXd) | Experimental | Drug: trastuzumab deruxtecan (T-DXd), Drug: GI-102 |
| GI-102 + pembrolizumab | Experimental | Drug: pembrolizumab, Drug: GI-102 |
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 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.
Key exclusion criteria (14 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.
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-102 subcutaneous (SC)0.12 mg/kg, 0.24 mg/kg or Recommended phase 2 dose of GI-102 will be administered via SC injection Q3W up to 2 years (approximately 35 years). | Drug | GI-102 subcutaneous (SC) |
| GI-102Dose level will be escalated from 0.06 mg/kg to 0.45 mg/kg and Recommended phase 2 dose (or RP2D-1, RP2D+1) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years). | Drug | GI-102 |
| doxorubicinDoxorubicin will be administered intravenously at a dose of 75 mg/m2 on Day 3 every 3-week (21-day) cycle for up to 6 cycles. | Drug | GI-102 + doxorubicin |
| paclitaxelPaclitaxel will be administered intravenously over 1 hour at a dose of 80 mg/m2 each time weekly as a diluted solution according to the prescribing information. | Drug | GI-102 + paclitaxel + bevacizumab |
| bevacizumabBevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks. | Drug | GI-102 + paclitaxel + bevacizumab |
| eribulinEribulin will be administered intravenously at a dose of over 1.4 mg/m2 over 2 to 5 minutes on Days 3 and 10 every 3-week (21-day) cycle. | Drug | GI-102 + eribulin |
| trastuzumab deruxtecan (T-DXd)Also: ENHERTU®T-DXd will be administered initially as a 5.4 mg/kg (or 6.4 mg/kg only for gastric cancer) IV over 30 - 90 minutes every 3 weeks. | Drug | GI-102 + trastuzumab deruxtecan (T-DXd) |
| pembrolizumabAlso: KEYTRUDA®pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W. | Drug | GI-102 + pembrolizumab |
| GI-102Recommended phase 2 dose (or RP2D-1, RP2D-2) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years). | Drug | GI-102 + doxorubicin, GI-102 + eribulin, GI-102 + paclitaxel + bevacizumab, GI-102 + pembrolizumab, GI-102 + trastuzumab deruxtecan (T-DXd) |
Primary outcome
Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B)
Time frame: Study Day 1, assessed up to DLT period (3 weeks after treatment)
A DLT is defined as a clinically significant AE (classified according to the NCI CTCAE version 5) or significant laboratory abnormality that occur during the DLT assessment periods, during dose escalation and dose expansion, and is considered by the Investigator to be related to GI-102.
Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose escalation phase of Part A and B)
Time frame: Study Day 1, assessed up to approximately 24 months
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Objective Response Rate (ORR) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D)
Time frame: Study Day 1, assessed up to approximately 24 months
ORR is defined as the percentage of participants with investigator-assessed objective response of complete response (CR) or partial response (PR). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
12 secondary outcomes
Objective Response Rate (ORR) (dose escalation phase of Part A and B)
Time frame: Study Day 1, assessed up to approximately 24 months
Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D)
Time frame: Study Day 1, assessed up to DLT period (3 weeks after treatment)
Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D)
Time frame: Study Day 1, assessed up to approximately 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-102
Time frame: Study Day 1, assessed up to approximately 24 months
Half-life of GI-102 (T1/2)
Time frame: Study Day 1, assessed up to approximately 24 months
Area under the plasma concentration versus time curve (AUC) of GI-102
Time frame: Study Day 1, assessed up to approximately 24 months
Clearance of GI-102
Time frame: Study Day 1, assessed up to approximately 24 months
Volume of distribution (Vd) of GI-102 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 25 Nov 2024.
- 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.
Nari Yun, PhD study director
GI Innovation, Inc.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GI-102 subcutaneous (SC), GI-102 and doxorubicin in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by GI Innovation, Inc. at 11 sites in 2 countries.
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 14 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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea, United States. 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 Jay Kim (+82-2-404-2003, Clinical-102@gi-innovation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B) (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 25 Nov 2024.