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
GigaGen, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willing and able to provide informed consent. * Histologically or cytologically confirmed locally advanced or radiographically confirmed metastatic solid tumor malignancies ineligible for standard-of-care or refractory to or relapsing after at least one line of systemic therapy in the metastatic or advanced setting. * Measurable disease on imaging as based on Response Evaluation Criteria in RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. * Life expectancy greater than three months. * Electrocardiogram (ECG) without evidence of clinicall…
Interventions
- DrugGIGA-564
Administered by intravenous infusion
- DrugGIGA-564
Administered by intravenous infusion
Location
- National Cancer InstituteBethesda, Maryland