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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (NCT06258304) is a Phase 1 interventional studying Advanced or Metastatic Solid Tumor Malignancies, sponsored by GigaGen, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced or Metastatic Solid Tumor Malignancies, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced or Metastatic Solid Tumor Malignancies subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Willing and able to provide willing to sign a consent form. - diagnosed by tissue sample (biopsy-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 clinically relevant abnormalities in rhythm, conduction, or morphology of resting ECG or active ischemia as determined by the Investigator. - Acceptable organ and marrow function including: 1. Absolute neutrophil count \>= 1,500 cells/ microliters (μL) 2. Platelets \>= 100,000 cells/μL 3. Hemoglobin \>= 9 grams per decilitre (g/dL) 4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN if attributable to known Gilbert's syndrome) 5. Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 2.5 × ULN. If liver metastasis is present, AST/ALT \< 5 × ULN 6. Measured kidney function (creatinine clearance) at least 30 milliliter per minute mL/min per Cockcroft-Gault formula 7. Prothrombin time or international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 × ULN, unless receiving anti-coagulant therapy. - Primary or metastatic lesions that are amenable to biopsy (Phase 1B only). - Women of childbearing potential must agree to use highly effective contraception. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 clinically relevant abnormalities in rhythm, conduction, or morphology of resting ECG or active ischemia as determined by the Investigator. * Acceptable organ and marrow function including: 1. Absolute neutrophil count \>= 1,500 cells/ microliters (μL) 2. Platelets \>= 100,000 cells/μL 3. Hemoglobin \>= 9 grams per decilitre (g/dL) 4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN if attributable to known Gilbert's syndrome) 5. Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 2.5 × ULN. If liver metastasis is present, AST/ALT \< 5 × ULN 6. Measured creatinine clearance ≥ 30 milliliter per minute mL/min per Cockcroft-Gault formula 7. Prothrombin time or international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 × ULN, unless receiving anti-coagulant therapy. * Primary or metastatic lesions that are amenable to biopsy (Phase 1B only). * Women of childbearing potential must agree to use highly effective contraception. Exclusion Criteria: * Investigational therapy and/or anti-cancer therapy with the potential for late onset toxicity within 4 weeks or 5 half-lives (whichever is shorter), or nitrosoureas or mitomycin C within 6 weeks. Food and drug administration (FDA)-approved hormonal therapies (e.g., androgen deprivation therapy \[ADT\] for prostate cancer, anti-estrogen for breast cancer, somatostatin analogue for neuroendocrine cancer) are allowed. * Failure to resolve toxicity from previous anti-cancer therapy (other than National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v5.0 ≤ Grade 2 alopecia, neuropathy or medically controlled endocrinopathies) to NCI CTCAE v5.0 ≤ Grade 1. * Prior receipt of therapy directed against CTLA-4. * Prior receipt of therapy directed against chemokine (C-C motif) receptor 8 (CCR8), cluster of differentiation 25 (CD25), or T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domains (TIGIT) with an active Fc domain. * Baseline prolongation of corrected QT interval (QTc) QT/QTc interval Fridericia's formula (QTcF \> 470 millisecond \[msec\]). * History of hepatitis B (HBV) infection unless viral load is undetectable. * Participants with known history of hepatitis C (HCV) infection, unless they have been treated and cured (viral load is undetectable). * Active or severe infection such as active tuberculosis. * Human immunodeficiency virus (HIV) infection unless participants are stable on anti-retroviral therapy (CD4 count ≥ 200/μL) and have a viral load \< 400 copies/mL. * Significant cardiovascular disease (such as New York Heart Association Class II or greater heart failure), myocardial infarction within 3 months prior to initiation of study treatment, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina. * Active or history of autoimmune or primary immunodeficiency disease requiring systemic treatment within 2 years of commencing study (NOTE: participants with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible). * Active or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). * History of hematopoietic stem cell transplantation (HSCT) or solid organ transplant with the exception of corneal transplants. * Pregnant or breastfeeding. * Previous hypersensitivity reactions to any component of the investigational product. * Concurrent use of systemic steroids (within 10 days of enrollment), except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in participants with exacerbations of reactive airway disease) must have completed therapy ≥ 10 days prior to enrollment. Steroid use to prevent intravenous contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed at any time prior to enrollment and for imaging while on treatment. * History of other active malignancy within 3 years of enrollment except for the following: adequately treated localized skin cancer, ductal carcinoma in situ, cervical carcinoma in situ, superficial bladder cancer or other localized malignancy which has been adequately treated. * Active or untreated brain metastases that are not stable. Stable is defined as 2 brain images that show no progression, obtained ≥ 4 weeks apart and any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved. Any steroids administered as part of this therapy must be completed ≥ 10 days prior to first dose of study medication. * Thymoma or thymic carcinoma (Phase 1A only). * Other medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and which, in the judgment of the Investigator or Sponsor, would make the patient inappropriate for the study.

Treatments Being Tested

DRUG

GIGA-564

Administered by intravenous infusion

DRUG

GIGA-564

Administered by intravenous infusion

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Cancer Institute
Bethesda, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06258304), the sponsor (GigaGen, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06258304 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06258304?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06258304?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06258304. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06258304. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.