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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)

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:


  1. Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
  2. Has adequate organ and marrow function as defined in protocol.
  3. Measurable disease as per RECIST v1.1.
  4. ECOG performance status 0-1.
  5. 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.
  6. HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol.

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Has known active CNS metastases and/or carcinomatous meningitis.
  2. An active second malignancy.
  3. Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.
  4. Has active tuberculosis or has a known history of active tuberculosis.
  5. Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.
  6. History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.
  7. Has an active autoimmune disease that has required systemic treatment in past 2 years.
  8. Previous immunotherapies related to mode of action of GI-102.
  9. 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.
  10. Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
  11. Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy.
  12. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.
  13. 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


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +82-2-404-2003Email iconEmail Study Center

Study Details


Contition

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)

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

358

Est. Completion Date

Apr 24, 2027

Treatment Type

INTERVENTIONAL


Sponsor

GI Innovation, Inc.

ClinicalTrials.gov NCT Identifier

NCT05824975

Study Number

GII-102-P101

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