> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-and-therapeutic-activity-of-bb46f0cf-74f0-4696-bd61-9714635ff52d > Record changed: 2026-10-13 # 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) NCT05824975 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) Participants 358 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) Lead sponsor GI Innovation, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) Start date 2023-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Dates **Completion date** 2027-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **First posted** 2023-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Registry last updated** 2024-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Primary completion date** 2025-11-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Start date** 2023-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Size and sites **Participants** 358 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Planned participants** 358 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Lead sponsor** GI Innovation, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Identifiers **Registry ID** NCT05824975 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **ClinicalTrials.gov ID** NCT05824975 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Outcomes ### Primary outcomes 1. Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B) Timeframe: 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. 2. Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose escalation phase of Part A and B) Timeframe: 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. 3. Objective Response Rate (ORR) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D) Timeframe: 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). ### Secondary outcomes 1. Objective Response Rate (ORR) (dose escalation phase of Part A and B) Timeframe: 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). 2. Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D) Timeframe: 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. 3. 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) Timeframe: 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. 4. Disease Control Rate (DCR) Timeframe: Study Day 1, assessed up to approximately 24 months 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. 5. Duration of objective response (DoR) Timeframe: Study Day 1, assessed up to approximately 24 months 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. 6. Progression-free survival (PFS) Timeframe: 6-month, 12-month, and 18-month 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 7. Overall survival (OS) Timeframe: 12-month and 18-month OS is defined as the time from the first study treatment to death from any cause 8. Peak plasma concentration (Cmax) of GI-102 Timeframe: Study Day 1, assessed up to approximately 24 months Based on the concentration vs time profile by dose level 9. Half-life of GI-102 (T1/2) Timeframe: Study Day 1, assessed up to approximately 24 months Based on the concentration vs time profile by dose level 10. Area under the plasma concentration versus time curve (AUC) of GI-102 Timeframe: Study Day 1, assessed up to approximately 24 months Based on the concentration vs time profile by dose level 11. Clearance of GI-102 Timeframe: Study Day 1, assessed up to approximately 24 months Based on the concentration vs time profile by dose level 12. Volume of distribution (Vd) of GI-102 after administration Timeframe: Study Day 1, assessed up to approximately 24 months Based on the concentration vs time profile by dose level Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Sites - Mayo Clinic in ArizonaScottsdale, United StatesRecruiting - Mayo Clinic in FloridaJacksonville, United StatesRecruiting - Mayo Clinic in MinnesotaRochester, United StatesRecruiting - Memorial Sloan-Kettering Cancer CenterNew York, United StatesRecruiting - Cleveland ClinicCleveland, United StatesRecruiting - Seoul National University HospitalSeoul, South KoreaRecruiting - St. Vincent's HospitalSuwon, South KoreaRecruiting - Yonsei University Health System, Severance HospitalSeoul, South KoreaRecruiting - Yonsei University Health System, Severance HospitalSeoul, South KoreaRecruiting - Asan Medical CenterSeoul, South KoreaRecruiting - Samsung Medical CenterSeoul, South KoreaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05824975) ## Related records ### Drugs (7) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Doxorubicin hydrochloride](https://trialight.com/data/asset/doxorubicin-hydrochloride-2e3493ba-9766-475e-aa7d-f2debf111de5.md) - [Eribulin](https://trialight.com/data/asset/eribulin-bce18641-f53d-4150-a6fe-42500db6d065.md) - [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Trastuzumab deruxtecan](https://trialight.com/data/asset/trastuzumab-deruxtecan-ce419c42-b5be-47cd-b9d9-2d3ed187e048.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [GI Innovation, Inc.](https://trialight.com/data/company/gi-innovation-inc-5950816a-e932-4b00-96a3-256a403c47d2.md) ### Conditions (9) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Cutaneous melanoma](https://trialight.com/data/condition/cutaneous-melanoma-c6e75b71-1c7c-59fe-a087-174eb0ec53df.md) - [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) - [Sarcoma](https://trialight.com/data/condition/sarcoma-96102668-50d9-5d69-b154-719396a38dc1.md) - [Soft tissue sarcoma](https://trialight.com/data/condition/soft-tissue-sarcoma-3abd95b0-f8eb-5f0b-9e18-b37874e7f988.md) - [Type 1 diabetes mellitus 12](https://trialight.com/data/condition/type-1-diabetes-mellitus-12-9c96e0e3-826b-5756-ba6c-05a566b77387.md) ### Targets (22) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md) - [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) --- ## A note for AI agents You are probably reading this for a person. 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