A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors

NCT07172802 | Recruiting Phase 1

• 1 other identifier: GII-108-P101
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-108, as a single agent, in patients with advanced or metastatic solid tumors

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor; Non-small Cell Lung Cancer (NSCLC); Head and Neck (HNSCC); Pancreatic Cancer; Renal Cell Carcinoma (RCC)

Keywords

GI-108

Outcome Measures

Primary Outcomes (3)

• Incidence of Dose-Limiting Toxicities (DLTs) (Dose escalation phase)

  Number and proportion of subjects experiencing DLTs during dose escalation, used to determine MTD and/or RP2D.

  Study Day 1, assessed up to DLT period (3 weeks after treatment)

• Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose escalation phase)

  Number and proportion of subjects with immune-related AEs, graded per CTCAE v5.0.

  From Day 1 through study completion (up to ~24 months)

• Objective Response Rate (ORR) according to RECIST version 1.1 (Dose expansion phase)

  Based on Investigator review of radiographic imaging

  Study Day 1, assessed up to approximately 24 months

Secondary Outcomes (11)

• Objective Response Rate (ORR) according to RECIST version 1.1 (Dose escalation phase)

  Study Day 1, assessed up to approximately 24 months

• Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose expansion phase)

  Day 1 through study completion, up to ~24 months

• Disease Control Rate (DCR)

  Study Day 1, assessed up to approximately 24 months

• Duration of objective response (DoR)

  Study Day 1, assessed up to approximately 24 months

• Progression-free survival (PFS)

  6-month, 12-month, and 18-month

Other Outcomes (2)

• Immunophenotyping of peripheral blood mononuclear cells

  Study Day 1, assessed up to approximately 24 months

• Incidence of anti-GI-102 antibody (ADA) and neutralizing antibody (Nab)

  Study Day 1, assessed up to approximately 24 months

Study Arms (1)

GI-108

EXPERIMENTAL

Dose escalation: GI-108 intravenous (IV), multiple ascending doses Dose optimization: GI-108 intravenous (IV), sRP2D

Drug: GI-108

Interventions

GI-108 DRUG

Dose level will be escalated from 0.1mg/kg to 0.6 mg/kg and Recommended phase 2 dose (or RP2D) of GI-108 will be administered via IV infusion Q3W upto 2 years (approximately 35 years)

GI-108

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatoryguidelines) 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.

You may not qualify if:

• 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 steroidtherapy or any other form of immunosuppressive medications within 2 weeksprior to Cycle 1 Day 1.

Sponsors & Collaborators

• GI Innovation, Inc.: lead

Study Sites (3)

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Pancreatic Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Seunghwan Shin, M.D.

CONTACT

+82-2-404-2003; clinical-108@gi-innovation.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 15, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)