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A Study of GI-102 for Advanced Solid Tumors

This study is testing a new drug called GI-102 for people with advanced or metastatic (spread throughout the body) solid tumors, including soft tissue sarcoma, platinum-resistant ovarian cancer, and hepatocellular carcinoma (a type of liver cancer). Researchers want to see how safe GI-102 is and how well it works, both on its own and when combined with other anti-cancer drugs like pembrolizumab or trastuzumab deruxtecan. You might be eligible if you are 18 or older, have measurable disease, and good overall health. The study will measure side effects and how many participants respond to the treatment.

Study design
This is an open-label (meaning you and your doctors will know what treatment you are receiving) study with an adaptive design, meaning it can change based on early results. It plans to enroll 358 participants.
What's involved
GI-102 will be given either as an injection under the skin or through a vein every three weeks for up to two years. Other drugs like doxorubicin, paclitaxel, or bevacizumab may also be given intravenously.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored for up to approximately 24 months. Treatment response will also be assessed for up to approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05824975

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
GI Innovation, Inc.
~358 participants
Updated 2024-11-25 on ClinicalTrials.gov
What's tested:GI-102 subcutaneous (SC)GI-102doxorubicinpaclitaxelbevacizumaberibulin

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B)
Measured over Study Day 1, assessed up to DLT period (3 weeks after treatment)
+2 more outcomes measured

Conditions

Advanced Solid Tumor
Metastatic Solid Tumor
Soft Tissue Sarcoma (STS)
Platinum-resistant Ovarian Cancer (PROC)
Hepatocellular Carcinoma (HCC)
Colorectal Cancer (CRC)
HER2 Negative Breast Cancer
Cutaneous Melanoma
Renal Cell Carcinoma (RCC)

Explore related trials

Breast CarcinomaColorectal CarcinomaHepatocellular CarcinomaMalignant Ovarian NeoplasmMelanomaRenal Cell CarcinomaSoft Tissue SarcomaSolid Neoplasm

Where it's being run

11 sites across 8 states
South Korea4
Arizona1
Florida1
Minnesota1
New York1
Ohio1
Seoul1
suwon1

Study leadership

  • Nari Yun, PhD · STUDY_DIRECTOR · GI Innovation, Inc.

Who to contact

Jay Kim
[email protected]
+82-2-404-2003
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B)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)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)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).