Actively Recruiting
A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Led by GigaGen, Inc. · Updated on 2025-04-10
60
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
Sponsors
G
GigaGen, Inc.
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 based on Response Evaluation Criteria in RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 4 1.
- Life expectancy greater than three months.
- Electrocardiogram (ECG) without clinically relevant abnormalities in rhythm, conduction, or morphology or active ischemia.
- Acceptable organ and marrow function including: absolute neutrophil count 3,500 cells/bcL; platelets 300,000 cells/bcL; hemoglobin 3 grams per decilitre; total bilirubin 4 1.5 �d7 upper limit of normal (ULN) (or 3 �d7 ULN if Gilbert's syndrome); AST/ALT 4 2.5 �d7 ULN (or 3 �d7 ULN if liver metastasis present); creatinine clearance 30 mL/min; prothrombin time or INR and PTT 4 1.5 �d7 ULN unless on anti-coagulants.
- Primary or metastatic lesions amenable to biopsy (Phase 1B only).
- Women of childbearing potential must agree to use highly effective contraception.
You will not qualify if you...
- Investigational or anti-cancer therapy with potential late toxicity within 4 weeks or 5 half-lives, or nitrosoureas or mitomycin C within 6 weeks. FDA-approved hormonal therapies allowed.
- Unresolved toxicity from prior anti-cancer therapy above Grade 1, except alopecia, neuropathy, or controlled endocrinopathies.
- Prior therapy directed against CTLA-4.
- Prior therapy directed against CCR8, CD25, or TIGIT with active Fc domain.
- Baseline corrected QT interval (QTcF) > 470 msec.
- History of hepatitis B unless viral load undetectable.
- History of hepatitis C unless treated and cured.
- Active or severe infections including active tuberculosis.
- HIV infection unless stable on anti-retroviral therapy with CD4 count ≥ 200/µL and viral load < 400 copies/mL.
- Significant cardiovascular disease including heart failure, recent myocardial infarction or stroke, unstable arrhythmia, or angina.
- Active or history of autoimmune or primary immunodeficiency disease needing systemic treatment within 2 years, except hormone replacement or topical treatments.
- Active or history of inflammatory bowel disease.
- History of hematopoietic stem cell or solid organ transplant except corneal transplants.
- Pregnant or breastfeeding.
- Previous hypersensitivity to any investigational product component.
- Recent systemic steroids use within 10 days except physiologic replacement or local steroids.
- History of other active malignancy within 3 years except certain treated localized cancers.
- Active or untreated unstable brain metastases.
- Thymoma or thymic carcinoma (Phase 1A only).
- Other medical or psychiatric conditions increasing risk or interfering with study participation as judged by Investigator or Sponsor.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Institute
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
James Gulley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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