← Back to Search

Monoclonal Antibodies

GIGA-564: Dose Escalation (Phase 1A) for Solid Tumor Malignancies

Q: Is the recruitment phase for this study still ongoing?

<p>According to information on clinicaltrials.gov, recruitment for this particular trial is not currently active. The trial was first listed on March 1st, 2024 and the most recent update occurred on February 6th, 2024. While this specific study is not enrolling participants at present, it's worth noting that there are a substantial number of 2532 other research investigations actively seeking patients.</p>

Q: What is the safety profile of GIGA-564: Dose Escalation (Phase 1A) in patient use?

<p>The safety assessment of GIGA-564: Dose Escalation (Phase 1A) by the Power team is rated as a 1 on a scale from 1 to 3. This rating reflects that since this trial is in Phase 1, there exists minimal data supporting both efficacy and safety.</p>

Phase 1

Recruiting

Research Sponsored by GigaGen, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acceptable organ and marrow function including: Absolute neutrophil count > 1,500 cells/ microliters (μL), Platelets > 100,000 cells/μL, Hemoglobin > 10 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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial aims to test the safety and side effects of a drug called GIGA-564 in patients with advanced solid tumors. Researchers want to find out the highest dose of the drug that can be

Who is the study for?

This trial is for people with advanced or widespread solid tumors. Participants must have a tumor that's grown despite treatment, or they can't receive other standard treatments. The exact eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.Check my eligibility

What is being tested?

The study is testing GIGA-564 to find the highest dose patients can take without serious side effects (MTD) and to decide on the best dose for future studies (RP2D). It's an early-phase trial focusing on safety and dosage levels.See study design

What are the potential side effects?

Specific side effects of GIGA-564 aren't listed here, but common ones in trials like this may include nausea, fatigue, allergic reactions, and potential harm to organs where the cancer has spread.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is advanced or has spread, and standard treatments haven't worked or it came back.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Number of Participants With Grade 3 or 4 TEAEs

+4 more

Secondary outcome measures

Accumulation Ratio for Area Under the Serum Concentration-time Curve (AUC) of GIGA-564

Accumulation Ratio for Maximum Observed Serum Concentration (Cmax) of GIGA-564

Accumulation Ratio for Trough Observed Serum Concentration (Ctrough) of GIGA-564

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: GIGA-564: Dose Expansion (Phase 1B)Experimental Treatment1 Intervention

Dose expansion will be initiated following the completion of dose escalation (Phase 1A). Participants will receive up to 4 cycles of one of up to two tolerable dose levels of GIGA-564. If two dose levels are selected, participants will be randomized 1:1 to the two dosing cohorts. 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.

Group II: GIGA-564: Dose Escalation (Phase 1A)Experimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

GigaGen, Inc.Lead Sponsor

1 Previous Clinical Trials

3 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,675 Previous Clinical Trials

40,926,927 Total Patients Enrolled

3 Trials studying Solid Tumor Malignancies

109 Patients Enrolled for Solid Tumor Malignancies

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase for this study still ongoing?

"According to information on clinicaltrials.gov, recruitment for this particular trial is not currently active. The trial was first listed on March 1st, 2024 and the most recent update occurred on February 6th, 2024. While this specific study is not enrolling participants at present, it's worth noting that there are a substantial number of 2532 other research investigations actively seeking patients."

Answered by AI

What is the safety profile of GIGA-564: Dose Escalation (Phase 1A) in patient use?

"The safety assessment of GIGA-564: Dose Escalation (Phase 1A) by the Power team is rated as a 1 on a scale from 1 to 3. This rating reflects that since this trial is in Phase 1, there exists minimal data supporting both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06258304.