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

NCT06258304 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: GG-GIGA-564-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced or Metastatic Solid Tumor Malignancies

Keywords

GIGA-564, CTLA-4

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to 154 days

• Number of Participants With Grade 3 or 4 TEAEs

  Up to 154 days

• Number of Participants With Treatment-related TEAEs

  Up to 154 days

• Number of Participants With Grade 3 or 4 Treatment-related TEAEs

  Up to 154 days

• Number of Participants With Serious Adverse Events (SAE's)

  Up to 154 days

• Number of Participants Who Discontinued Treatment due to Adverse Events (AEs)

  Up to 154 days

• Number of Participants With Dose-limiting Toxicities (DLTs) during Cycle 1

  Up to 21 days

Secondary Outcomes (16)

• Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Up to Week 24

• Percentage of Participants with Minor RECIST 1.1 Response

  Up to Week 24

• Disease Control Rate (DCR) per RECIST 1.1

  Up to Week 24

• Progression Free Survival (PFS)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

Study Arms (2)

GIGA-564: Dose Escalation (Phase 1A)

EXPERIMENTAL

Up to 5 dose levels \[0.3, 1.0, 3.0, 10.0, and 20.0 milligrams per kilogram (mg/kg)\] will be evaluated sequentially. Participants will receive GIGA-564 intravenously over at least 60 minutes on Day 1 of every 3 weeks (3 weeks = 1 cycle) for up to 4 cycles until time of confirmed disease progression, unacceptable toxicity, or other reason for treatment discontinuation.

Drug: GIGA-564

GIGA-564: Dose Expansion (Phase 1B)

EXPERIMENTAL

Dose expansion (Phase 1B) of selected dose levels may be initiated following the preliminary clearance of those specified dose levels from the dose escalation (Phase 1A) as determined by the Sponsor and SRC. Participants will receive up to 4 cycles of one of up to three tolerable dose levels of GIGA-564. GIGA-564 will be given intravenously over at least 60 minutes on Day 1 of every 3 weeks (3 weeks = 1 cycle) for up to 4 cycles until time of confirmed disease progression, unacceptable toxicity, or other reason for treatment discontinuation.

Drug: GIGA-564

Interventions

GIGA-564 DRUG

Administered by intravenous infusion

GIGA-564: Dose Escalation (Phase 1A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count \>= 1,500 cells/ microliters (μL)
• Platelets \>= 100,000 cells/μL
• Hemoglobin \>= 9 grams per decilitre (g/dL)
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN if attributable to known Gilbert's syndrome)
• Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 2.5 × ULN. If liver metastasis is present, AST/ALT \< 5 × ULN
• Measured creatinine clearance ≥ 30 milliliter per minute mL/min per Cockcroft-Gault formula
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GigaGen, Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

National Cancer Institute

Bethesda, Maryland, 20892, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Insulin-Dependent, 12

Central Study Contacts

James Gulley

CONTACT

888-624-1937; ncimo_referrals@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: May 8, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)