Advanced or Metastatic Solid Tumor MalignanciesPhase 1NCT06258304
A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
A Phase 1 study testing GIGA-564 in people with Advanced or Metastatic Solid Tumor Malignancies, run by GigaGen, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumor Malignancies
- What is being tested?
- GIGA-564
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- Women of childbearing potential must agree to use highly effective contraception.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Cancer Institute
Bethesda, Maryland, 20892
About this study
Official title: 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
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.
- Being tested
- GIGA-564
- Keywords
- GIGA-564, CTLA-4
- Medical subject headings
- Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIGA-564Drug
Administered by intravenous infusion
GIGA-564Drug
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: GIGA-564 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 154 days
Number of Participants With Grade 3 or 4 TEAEs
Measured: Up to 154 days
Number of Participants With Treatment-related TEAEs
Measured: Up to 154 days
Number of Participants With Grade 3 or 4 Treatment-related TEAEs
Measured: Up to 154 days
Number of Participants With Serious Adverse Events (SAE's)
Measured: Up to 154 days
Number of Participants Who Discontinued Treatment due to Adverse Events (AEs)
Measured: Up to 154 days
Number of Participants With Dose-limiting Toxicities (DLTs) during Cycle 1
Measured: Up to 21 days
Secondary outcomes (16)
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: Up to Week 24
Percentage of Participants with Minor RECIST 1.1 Response
Measured: Up to Week 24
Disease Control Rate (DCR) per RECIST 1.1
Measured: Up to Week 24
Progression Free Survival (PFS)
Measured: Up to 2 years
Duration of Response (DOR)
Measured: Up to 2 years
Area Under the Serum Concentration-time Curve during a Dosage Interval (AUC0-tau) of GIGA-564 during Cycle 1 and Cycle 4
Measured: Up to 84 days
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC[0-inf)] of GIGA-564 during Cycle 1
Measured: Up to 21 days
Maximum Observed Serum concentration (Cmax) of GIGA-564 during Cycle 1 and Cycle 4
Measured: Up to 154 days
Time to Reach Maximum Observed Serum Concentration (Tmax) of GIGA-564 during Cycle 1 and Cycle 4
Measured: Up to 154 days
Trough Observed Serum Concentration (C trough) of GIGA-564 during Cycle 1 and Cycle 4
Measured: Up to 154 days
Elimination Half-life (t1/2) of GIGA-564 during Cycle 1 and Cycle 4
Measured: Up to 154 days
Apparent Total Body Clearance (CL) of GIGA-564 during Cycle 1
Measured: Up to 21 days
Volume of Distribution at Steady State (Vss) of GIGA-564 during Cycle 1
Measured: Up to 21 days
Accumulation Ratio for Maximum Observed Serum Concentration (Cmax) of GIGA-564
Measured: Up to 154 days
Accumulation Ratio for Trough Observed Serum Concentration (Ctrough) of GIGA-564
Measured: Up to 154 days
Accumulation Ratio for Area Under the Serum Concentration-time Curve (AUC) of GIGA-564
Measured: Up to 154 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start8 May 2024
- Primary completionApr 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid Tumor MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GigaGen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258304
- Sponsor's protocol ID
- GG-GIGA-564-001
- Status last verified
- Apr 2025
- First submitted
- 6 Feb 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06258304
- Acronym / sponsor ID
- GG-GIGA-564-001
- Keywords
- GIGA-564, CTLA-4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GigaGen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 May 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIGA-564: Dose Escalation (Phase 1A) | Experimental | Drug: GIGA-564Up 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. |
| GIGA-564: Dose Expansion (Phase 1B) | Experimental | Drug: GIGA-564Dose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (20 listed)
- 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]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIGA-564Administered by intravenous infusion | Drug | GIGA-564: Dose Escalation (Phase 1A) |
| GIGA-564Administered by intravenous infusion | Drug | GIGA-564: Dose Expansion (Phase 1B) |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 154 days
Number of Participants With Grade 3 or 4 TEAEs
Time frame: Up to 154 days
Number of Participants With Treatment-related TEAEs
Time frame: Up to 154 days
Number of Participants With Grade 3 or 4 Treatment-related TEAEs
Time frame: Up to 154 days
Number of Participants With Serious Adverse Events (SAE's)
Time frame: Up to 154 days
Number of Participants Who Discontinued Treatment due to Adverse Events (AEs)
Time frame: Up to 154 days
Number of Participants With Dose-limiting Toxicities (DLTs) during Cycle 1
Time frame: Up to 21 days
16 secondary outcomes
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to Week 24
Percentage of Participants with Minor RECIST 1.1 Response
Time frame: Up to Week 24
Disease Control Rate (DCR) per RECIST 1.1
Time frame: Up to Week 24
Progression Free Survival (PFS)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Area Under the Serum Concentration-time Curve during a Dosage Interval (AUC0-tau) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 84 days
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC[0-inf)] of GIGA-564 during Cycle 1
Time frame: Up to 21 days
Maximum Observed Serum concentration (Cmax) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 154 days
Time to Reach Maximum Observed Serum Concentration (Tmax) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 154 days
Trough Observed Serum Concentration (C trough) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 154 days
Elimination Half-life (t1/2) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 154 days
Apparent Total Body Clearance (CL) of GIGA-564 during Cycle 1
Time frame: Up to 21 days
Volume of Distribution at Steady State (Vss) of GIGA-564 during Cycle 1
Time frame: Up to 21 days
Accumulation Ratio for Maximum Observed Serum Concentration (Cmax) of GIGA-564
Time frame: Up to 154 days
Accumulation Ratio for Trough Observed Serum Concentration (Ctrough) of GIGA-564
Time frame: Up to 154 days
Accumulation Ratio for Area Under the Serum Concentration-time Curve (AUC) of GIGA-564
Time frame: Up to 154 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GIGA-564 in people with Advanced or Metastatic Solid Tumor Malignancies, run by GigaGen, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Gulley (888-624-1937, ncimo_referrals@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 154 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.