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GLR2007 for Glioblastoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Gan and Lee Pharmaceuticals, USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial is testing a new drug, GLR2007, to see if it is safe and effective in treating people with advanced solid tumors.

Eligible Conditions
  • Glioblastoma
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months 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 Escalation: Dose-limiting Toxicities
Dose Escalation: Incidence And Severity Of Adverse Events, Including The Incidence Of Dose-limiting Toxicities Within The First Cycle
Dose Expansion: Incidence And Severity Of Adverse Events
Secondary outcome measures
Dose Escalation And Expansion: Accumulation Ratio After Single And Multiple Oral Dose Administrations
Dose Escalation And Expansion: Area Under The Plasma Concentration-time Curve From 0 To Last Measurable Concentration And From 0 To Infinity After Single And Multiple Oral Dose Administrations
Dose Escalation And Expansion: Clearance After Single And Multiple Oral Dose Administrations
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2: Dose Expansion - Cohort CExperimental Treatment1 Intervention
Participants experiencing their first recurrence glioblastoma multiforme (GBM) will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression.
Group II: Part 2: Dose Expansion - Cohort BExperimental Treatment1 Intervention
Participants who have received 2 or more second-line therapies, with at least 1 line of standard therapy, for their brain metastases of breast or NSCLC origin will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression.
Group III: Part 2: Dose Expansion - Cohort AExperimental Treatment1 Intervention
Participants who have received 2 or more second-line therapies, with at least 1 line of standard therapy, for their non-small cell lung cancer (NSCLC) will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression.
Group IV: Part 1: Dose EscalationExperimental Treatment1 Intervention
Dose escalation cohorts are planned to determine the maximum tolerated dose or recommended phase 2 dose of GLR-2007, as well as expansion cohorts and a Phase 2 cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLR2007
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Gan and Lee Pharmaceuticals, USALead Sponsor
14 Previous Clinical Trials
2,432 Total Patients Enrolled
Kimberly Lazaroff, MSNStudy DirectorGan and Lee Pharmaceuticals, USA Corp
1 Previous Clinical Trials
24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of GLR2007 for Advanced Solid Tumors
2020. "Evaluation of GLR2007 for Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04444427.
~4 spots leftby Apr 2025
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