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GI-102 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by GI Innovation, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month, 12-month, and 18-month

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a new drug to treat advanced or metastatic cancers.

Who is the study for?

Adults with advanced solid tumors who have good organ and bone marrow function, measurable disease, a performance status indicating they can care for themselves (ECOG 0-1), and no severe recent side effects from past cancer treatments. HIV+ patients must be on effective ART. Not eligible if they have active brain metastases, another cancer, hepatitis B or C infections, tuberculosis, uncontrolled infections, recent immunotherapies like GI-102's action mode or any cancer treatment within the last month.Check my eligibility

What is being tested?

The trial is testing GI-102 as a single agent to see how safe it is and how well it works against different types of advanced or spreading solid tumors. It will look at how the body processes the drug and its effectiveness in shrinking or controlling tumor growth.See study design

What are the potential side effects?

Specific side effects of GI-102 are not listed but generally may include typical reactions such as fatigue, nausea, inflammation at injection sites, allergic reactions to components of the drug product/excipients of GI-102.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month, 12-month, and 18-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month, 12-month, and 18-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month, 12-month, and 18-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase)

Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose escalation phase)

Objective Response Rate (ORR) (dose expansion phase)

Secondary outcome measures

Area under the plasma concentration versus time curve (AUC) of GI-102

Clearance of GI-102

Disease Control Rate (DCR)

+8 more

Other outcome measures

Immunophenotyping of peripheral blood CD4+ T cells

Immunophenotyping of peripheral blood CD8+ T cells

Immunophenotyping of peripheral blood Treg cells

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose expansion phase : GI-102 as a single agentExperimental Treatment1 Intervention

Dose expansion: GI-102, tentative RP2D

Group II: Dose escalation phase : GI-102 as a single agentExperimental Treatment1 Intervention

Dose escalation: GI-102, multiple ascending doses

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GI Innovation, Inc.Lead Sponsor

1 Previous Clinical Trials

430 Total Patients Enrolled

Nari Yun, PhDStudy DirectorGI Innovation, Inc.

1 Previous Clinical Trials

430 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants being accepted into this research study at the moment?

"Evidently, this medical trial is presently seeking to enroll participants. According to the clinicaltrials.gov listing, it was first posted on May 30th 2023 and recently updated on September 11th 2023."

Answered by AI

How many research venues are currently conducting this experiment?

"Seven facilities are involved in this study, including Mayo Clinic's Florida and Minnesota locations as well as Cleveland Clinic. An additional four medical centres also collaborate on the research."

Answered by AI

How many subjects are engaged in this experiment?

"To successfully run the study, 92 participants who meet the criteria must be recruited. GI Innovation, Inc., is overseeing this trial and it will take place in two Mayo Clinics situated in Jacksonville, Florida and Rochester Minnesota."

Answered by AI

What is the fundamental aim of this medical experiment?

"GI Innovation, Inc. disclosed that the primary endpoint of this experiment will be Objective Response Rate (ORR) evaluated over 24 months. Secondary outcomes include Area under the plasma concentration versus time curve (AUC), Volume of distribution (Vd), and Peak Plasma Concentration (Cmax). These metrics shall be derived from data collected on Study Day 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Therapeutic Activity of GI-102 in Patients With Advanced Solid Tumors

2023. "A Study to Evaluate the Safety and Therapeutic Activity of GI-102 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05824975.