Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
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)

Led by GI Innovation, Inc. · Updated on 2024-11-25

358

Participants Needed

11

Research Sites

203 weeks

Total Duration

On this page

Sponsors

G

GI Innovation, Inc.

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 63 18 years (or 63 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 61, 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.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

2

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

3

Mayo Clinic in Minnesota

Rochester, Minnesota, United States, 55905

Actively Recruiting

4

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

5

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

6

Seoul National University Hospital

Seoul, Seoul, South Korea, 03080

Actively Recruiting

7

St. Vincent's Hospital

Suwon, suwon, South Korea, 12647

Actively Recruiting

8

Yonsei University Health System, Severance Hospital

Seoul, South Korea, 03722

Actively Recruiting

9

Yonsei University Health System, Severance Hospital

Seoul, South Korea, 03722

Actively Recruiting

10

Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

11

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

J

Jay Kim

CONTACT

W

Woosun Lee

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

7

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