RecruitingPhase 1NCT06258304

A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

A Phase 1 Dose Escalation and Expansion Study of GIGA-564, a Minimally Blocking Anti-CTLA-4 Monoclonal Antibody, in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies


Sponsor

GigaGen, Inc.

Enrollment

60 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the safety and tolerability of GIGA-564 and identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) level(s) of GIGA-564 in participants with metastatic or locally advanced solid tumor malignancies.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental cancer drug called GIGA-564 in people with advanced or metastatic solid tumors. The drug works by helping the immune system recognize and attack cancer cells. This is a dose-finding study to determine the safest and most effective doses. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic solid tumor that no longer responds to standard treatments - Your cancer is measurable on imaging scans - You are in good general health (ECOG score 0 or 1) - Your life expectancy is more than 3 months - Your heart, liver, kidney, and blood counts meet minimum requirements **You may NOT be eligible if...** - You received other investigational treatments recently (within 4 weeks or 5 half-lives) - You have active autoimmune disease requiring treatment - You have untreated or unstable brain metastases - You are pregnant or breastfeeding - You have significant heart rhythm problems or recent heart attack - You have active, uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGIGA-564

Administered by intravenous infusion

DRUGGIGA-564

Administered by intravenous infusion


Locations(1)

National Cancer Institute

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT06258304


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