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Phase 1b: Dose expansion-GSK5764227 for Tumors

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Male or female participants at least 18 years of age (≥18 years)
* Participants with advanced/metastatic tumors who have progressed on or are intolerant to all available standard of care therapies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 33 months
Awards & highlights

Summary

The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of GSK5764227. The study will also see how the levels of GSK5764227 change over time at different dose amounts.

Who is the study for?
This trial is for individuals with advanced solid tumors. Specific eligibility criteria are not provided, but typically participants must have measurable disease and adequate organ function, and may need to meet certain lab value thresholds.
What is being tested?
The study is testing GSK5764227's safety, how well it's tolerated by patients, its effectiveness against tumors, and how the body processes it at various doses. Topotecan is also being used; possibly as a comparison or in combination.
What are the potential side effects?
While specific side effects aren't listed here, drugs like GSK5764227 often cause symptoms such as nausea, fatigue, diarrhea or constipation. Side effects can vary widely based on individual patient factors.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 33 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 33 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
Phase 1a: Number of participants with AEs and serious adverse events (SAEs) by severity
Phase 1a: Number of participants with AEs leading to dose modifications
Phase 1a: Number of participants with Adverse Events (AEs)
+4 more
Secondary outcome measures
Phase 1a and Phase 1b: Area under concentration from 0 to t (AUC 0-t) of GSK5764227
Phase 1a and Phase 1b: Disease control rate (DCR)
Phase 1a and Phase 1b: Duration of Response (DoR)
+13 more

Side effects data

From 2019 Phase 2 trial • 35 Patients • NCT01931098
78%
Hypertension
67%
Fatigue
44%
Diarrhea
33%
Vomiting
33%
White blood cell decreased
33%
Cognitive disturbance
33%
Dysgeusia
33%
Seizure
33%
Nausea
22%
Weight loss
22%
Muscle weakness left-sided
22%
Anorexia
22%
Cough
22%
Gait disturbance
22%
Headache
22%
Neutrophil count decreased
22%
Pain
11%
Gastroesophageal reflux disease
11%
Musculoskeletal and connective tissue disorder - Other, specify
11%
Alanine aminotransferase increased
11%
Anemia
11%
Arthralgia
11%
Aspartate aminotransferase increased
11%
Bruising
11%
Depression
11%
Dizziness
11%
Dry mouth
11%
Dry skin
11%
Dysphagia
11%
Dysphasia
11%
Fall
11%
Flank pain
11%
Flu like symptoms
11%
Hematuria
11%
Hoarseness
11%
Hypernatremia
11%
Insomnia
11%
Lymphocyte count decreased
11%
Paresthesia
11%
Purpura
11%
Respiratory, thoracic and mediastinal disorders - Other, Congestion
11%
Sinus tachycardia
11%
Sinusitis
11%
Skin and subcutaneous tissue disorders - Other, Lacerations on legs
11%
Sore throat
11%
Spasticity
11%
Urinary urgency
11%
Oral pain
11%
Meningitis
11%
Eye disorders - Other, Left upper quadrant defect
11%
Gastrointestinal disorders - Other, specify
11%
Stroke
11%
Platelet count decreased
11%
Eye disorders - Other, Right Hemianops
11%
Hypoalbuminemia
11%
Hypocalcemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure
Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 1b: Dose expansion-GSK5764227Experimental Treatment1 Intervention
Group II: Phase 1a: Dose escalation-GSK5764227Experimental Treatment1 Intervention
Group III: Phase 1b: Dose expansion- TopotecanActive Control1 Intervention

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,784 Previous Clinical Trials
8,123,743 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
~173 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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