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GLB-001 for Acute Myeloid Leukemia

Phase 1

Recruiting

Research Sponsored by GluBio Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Participants must have specific screening laboratory values for WBC, AST, ALT, serum total bilirubin, estimated serum creatinine clearance, INR, aPTT, life expectancy, ECOG Performance Status, and negative pregnancy test for female Participants of child-bearing potential.

Participants is ≥ 18 years of age at the time of signing the Informed Consent Form (ICF).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial studies the safety & effectiveness of GLB-001, a new drug, to treat people with relapsed/refractory AML or HR-MDS. Up to 66 people are involved, and safety, dosing, and efficacy will be evaluated.

Who is the study for?

This trial is for adults over 18 with relapsed or refractory acute myeloid leukemia (R/R AML) or higher-risk myelodysplastic syndromes (HR-MDS). They must have failed or be ineligible for other treatments and meet specific health criteria like blood counts, liver and kidney function. Pregnant women are excluded.Check my eligibility

What is being tested?

GLB-001, an oral medication, is being tested in this Phase 1 study on patients with certain types of blood cancers. The study has two parts: dose escalation to assess safety and dosage levels, followed by dose expansion to find the most effective yet tolerable dose for future studies.See study design

What are the potential side effects?

While not specified here, typical side effects in such trials may include nausea, fatigue, diarrhea, risk of infection due to low white blood cell count, bleeding complications from low platelets and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

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

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My blood tests and health status meet the study's requirements.

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I am 18 years or older and can sign the consent form.

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I have been diagnosed with AML or HR-MDS according to WHO criteria.

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My AML or HR-MDS has not improved with available treatments.

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

Dose-limiting Toxicity (DLT)

Incidence of Adverse Events (AEs)

Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)

+1 more

Secondary outcome measures

CR Rate in Participants with Higher Risk Myelodysplastic Syndromes (HR-MDS)

CR with Incomplete Hematologic Recovery (CRi) Rate in Participants with AML

CR with Partial Hematological Recovery (CRh) Rate in Participants with AML

+31 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1bExperimental Treatment1 Intervention

Part 1b (Dose Expansion) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R AML and R/R HR-MDS participants.

Group II: Dose Escalation of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1aExperimental Treatment1 Intervention

Part 1a (Dose Escalation) of the study will enroll R/R AML and R/R HR-MDS participants and will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001 administered orally, and determine the maximum tolerated dose/maximum administered dose (MTD/MAD) in R/R AML or R/R HR-MDS patients who are eligible for dose limiting toxicity (DLT) evaluation.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

GluBio Therapeutics Inc.Lead Sponsor

Lu Gang, Ph.D.Study DirectorGluBio Therapeutics Inc.

Gang Lu, Ph.D.Study DirectorGluBio Therapeutics Inc.

2 Previous Clinical Trials

218 Total Patients Enrolled

Frequently Asked Questions

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

How large is the group of participants for this clinical testing?

"Affirmative. Information found on clinicaltrials.gov asserts that this medical trial, which was first uploaded on November 21st 2023, is actively looking for participants. Altogether, 48 patients are needed from 4 separate healthcare facilities."

Answered by AI

Are new participants still being accepted for this experiment?

"The clinical trial listing hosted on clinicaltrials.gov indicates that recruitment is still ongoing for this medical research project, which was initially posted and updated on the 21st of November 2023."

Answered by AI

What is the intent of this research endeavor?

"This trial will focus on measuring the Dose-Limiting Toxicity (DLT) of a certain drug over two years. Alongside DLT, secondary assessments such as Area under the concentration-time curve from 0 to infinity (AUC0-∞), The time to reach maximum concentration (Tmax), and Terminal half-life(T1/2) are also being tracked."

Answered by AI

Are there multiple health care centers executing this experiment in the city?

"Across 4 different sites, potential participants can join this clinical trial. The University of Kansas Medical Center Research Institute, Inc., Alliance for Multispecialty Research, LLC in Merriam and Memorial Sloan Kettering Cancer Center -David H. Koch Centre are among those recruiting patients as well as an additional four centres in the area."

Answered by AI

Has the FDA sanctioned a Phase 1a trial of GLB-001 as an individual therapy for patients with Relapsed/Refractory Acute Myeloid Leukemia or HR-MDS?

"Our team at Power has assigned Dose Escalation of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1a a score of 1, since it is still only in phase one. Meaning there are insufficient data to substantiate its efficacy or safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes

2024. "A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06146257.

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