Health Trials

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)

ConditionsAdvanced Solid TumorMetastatic Solid TumorSoft Tissue Sarcoma (STS)Platinum-resistant Ovarian Cancer (PROC)Hepatocellular Carcinoma (HCC)Colorectal Cancer (CRC)HER2 Negative Breast CancerCutaneous MelanomaRenal Cell Carcinoma (RCC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGI Innovation, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • GI-102 subcutaneous (SC)
  • GI-102
  • doxorubicin
  • paclitaxel
  • bevacizumab
  • eribulin
  • trastuzumab deruxtecan (T-DXd)
  • pembrolizumab
  • GI-102

Treatment groups

358 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

11
South Korea
Seoul National University Hospital03080, SeoulSeoul, South Korea
St. Vincent's Hospital12647, Suwonsuwon, South Korea
Asan Medical Center05505, Seoul South Korea
Samsung Medical Center06351, Seoul South Korea

Sponsors and collaborators

GI Innovation, Inc.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov