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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)

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.

ClinicalTrials.gov IDNCT05824975

PhasePHASE1, PHASE2

Enrollment358

SponsorGI Innovation, Inc.

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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)

About this study

Interventions

Drug: GI-102 subcutaneous (SC) — 0.12 mg/kg, 0.24 mg/kg or Recommended phase 2 dose of GI-102 will be administered via SC injection Q3W up to 2 years (approximately 35 years).
Drug: GI-102 — Dose level will be escalated from 0.06 mg/kg to 0.45 mg/kg and Recommended phase 2 dose (or RP2D-1, RP2D+1) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
Drug: doxorubicin — Doxorubicin will be administered intravenously at a dose of 75 mg/m2 on Day 3 every 3-week (21-day) cycle for up to 6 cycles.
Drug: paclitaxel — Paclitaxel will be administered intravenously over 1 hour at a dose of 80 mg/m2 each time weekly as a diluted solution according to the prescribing information.
Drug: bevacizumab — Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks.
Drug: eribulin — Eribulin will be administered intravenously at a dose of over 1.4 mg/m2 over 2 to 5 minutes on Days 3 and 10 every 3-week (21-day) cycle.
Drug: trastuzumab deruxtecan (T-DXd) — T-DXd will be administered initially as a 5.4 mg/kg (or 6.4 mg/kg only for gastric cancer) IV over 30 - 90 minutes every 3 weeks.
Drug: pembrolizumab — pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
Drug: GI-102 — Recommended phase 2 dose (or RP2D-1, RP2D-2) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).

Primary outcomes

Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B) (Study Day 1, assessed up to DLT period (3 weeks after treatment))
Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose escalation phase of Part A and B) (Study Day 1, assessed up to approximately 24 months)
Objective Response Rate (ORR) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D) (Study Day 1, assessed up to approximately 24 months)

Eligibility information

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 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. * HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol. Key Exclusion Criteria: * 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

Study locations

Mayo Clinic in Arizona, Scottsdale, Arizona 85259 United States
Mayo Clinic in Florida, Jacksonville, Florida 32224 United States
Mayo Clinic in Minnesota, Rochester, Minnesota 55905 United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10065 United States
Cleveland Clinic, Cleveland, Ohio 44195 United States
Seoul National University Hospital, Seoul, Seoul 03080 South Korea
St. Vincent's Hospital, Suwon, suwon 12647 South Korea
Yonsei University Health System, Severance Hospital, Seoul, 03722 South Korea
Yonsei University Health System, Severance Hospital, Seoul, 03722 South Korea
Asan Medical Center, Seoul, 05505 South Korea

Showing 10 of 11 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.