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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 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-09-15

No results posted yet for this study

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)

Interventions

DRUG

GI-108

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)

Sponsors & Collaborators

  • GI Innovation, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2027-02-28
Completion
2027-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172802 on ClinicalTrials.gov