Advanced or Metastatic Solid Tumor Malignancies study: GIGA-564
Official title A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT06258304
What this study is testing
What is GIGA-564?
GIGA-564 is an investigational intravenous infusion being studied as a potential treatment for advanced or metastatic solid tumor malignancies.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether GIGA‑564 is safe and how much people can take. It also looks for the best dose for future studies.
- Who it's for
- You may be able to join if you have a solid tumor that has spread or is hard to treat and you are not in another trial.
- What's involved
- You will receive injections of GIGA‑564 at a clinic. The team will monitor you for side effects and check your health with blood tests and scans.
- Time commitment
- The study lasts about 6 weeks, with several clinic visits and follow‑up appointments to track your safety and response.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to provide informed consent.
- Histologically or cytologically confirmed locally advanced or radiographically confirmed metastatic solid tumor malignancies ineligible for...
- 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.
You likely can't join 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)...
- Failure to resolve toxicity from previous anti-cancer therapy (other than National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI...
- 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...
- 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.
See the full eligibility 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...
- 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.
- 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.
- 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.
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.