A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
GlaxoSmithKline
Study ID
NCT06431594
Phase
PHASE1
Status
Recruiting

Conditions

  • Neoplasms
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GSK5733584 — DRUG
    GSK5733584 will be administered

Study Details

The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.

Key Dates

Start date
Jul 2, 2024
Status verified
May 2026
Primary completion
Sep 22, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
675 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
    Participants with advanced solid tumors who are refractory or intolerant to established standard therapies
  • Experimental: Part 2: Dose Expansion
    Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)

Primary Outcome Measure

Part 1: Number of participants with dose limiting toxicity (DLT) [ Time Frame: Up to 21 days ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBirminghamAlabama35294
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Charles Leath (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteFountain ValleyCalifornia92708
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Amol Rao (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSanta RosaCalifornia95403
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Ian Anderson (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteLake MaryFlorida32746-
GSK Investigational SiteOrlandoFlorida32827
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Cesar Perez Batista (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteFairwayKansas66205
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Andrea Jewell (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteBostonMassachusetts02114
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Sara Bouberhan (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteBostonMassachusetts02215
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Elizabeth Lee (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDetroitMichigan48201
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Ira Winer (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteGrand RapidsMichigan49546
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Nehal Lakhani (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMinneapolisMinnesota55455
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Deanna Teoh (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMineolaNew York11501
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Bhavana Pothuri (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNew YorkNew York10016
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Bhavana Pothuri (PRINCIPAL_INVESTIGATOR)
GSK Investigational SitePortlandOregon97213
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Christopher Darus (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNashvilleTennessee37203
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Denise Yardley (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDallasTexas75230
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Reva Schneider (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteWest Valley CityUtah84119
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
William McKean (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSeattleWashington98104
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Fernanda Musa (PRINCIPAL_INVESTIGATOR)

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