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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 17, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07172802). This is a study registration, not published results. Lead sponsor: GI Innovation, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 102 participants (ESTIMATED). 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. Primary outcome measures: Incidence of Dose-Limiting Toxicities (DLTs) (Dose escalation phase) , Study Day 1, assessed up to DLT period (3 weeks after treatment); Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose escalation phase) , From Day 1 through study completion (up to ~24 months); Objective Response Rate (ORR) according to RECIST version 1.1 (Dose expansion phase) , Study Day 1, assessed up to approximately 24 months. 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