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 Phase 1 Phase 2 Interventional Study
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)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
358 (estimated)
Sponsor
GI Innovation, Inc. · Industry
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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.

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * 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 re…
Contacts

Jay Kim

+82-2-404-2003

Clinical-102@gi-innovation.com

CONTACT

Woosun Lee

+82-2-404-2003

Clinical-102@gi-innovation.com

CONTACT