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.

Sponsors and collaborators

GI Innovation, Inc.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov