A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)

Part of paid clinical trials in Stanford, California.

Sponsor
GlaxoSmithKline
Study ID
NCT06551142
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • Ris-Rez — BIOLOGICAL
    Ris-Rez will be administered
  • Cisplatin — DRUG
    Cisplatin will be administered
  • Carboplatin — DRUG
    Carboplatin will be administered
  • Atezolizumab — BIOLOGICAL
    Atezolizumab will be administered
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab will be administered
  • Durvalumab — BIOLOGICAL
    Durvalumab will be administered
  • Cetuximab — BIOLOGICAL
    Cetuximab will be administered
  • Bevacizumab — BIOLOGICAL
    Bevacizumab will be administered
  • Tarlatamab — BIOLOGICAL
    Tarlatamab will be administered
  • Dostarlimab — BIOLOGICAL
    Dostarlimab will be administered

Study Details

The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227. The study will also see how the levels of Ris-Rez will change over time at different dose amounts when administered alone and in combination with other medicines like carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab, tarlatamab, dostarlimab

Key Dates

Start date
Sep 30, 2024
Status verified
May 2026
Primary completion
Oct 16, 2028
Completion
Jun 8, 2029

Study Design

Enrollment
845 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a- Dose escalation- Monotherapy
  • Experimental: Phase 1a- Dose escalation- Combination therapy
  • Experimental: Phase 1b- Dose optimisation- Monotherapy
  • Experimental: Phase 1b- Dose optimisation- Combination therapy
  • Experimental: Phase 1b- Dose expansion- Monotherapy
  • Experimental: Phase 1b- Dose expansion- Combination therapy

Primary Outcome Measure

Phase 1a: Number of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 28 months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteStanfordCalifornia94063
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Christopher Chen (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDenverColorado80218
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Gerald Falchook (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNew HavenConnecticut06511
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Patricia LoRusso (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteFort WayneIndiana46804
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Sunil Babu (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteBostonMassachusetts02114
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Leon Pappas (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDetroitMichigan48201
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Wasif Saif (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNew BrunswickNew Jersey08903
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Sanjay Goel (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMyrtle BeachSouth Carolina29572
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Neal Shore (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNashvilleTennessee37203
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Benjamin Garmezy (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteAustinTexas78705
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Vivian Jean Mikao Cline (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDallasTexas75230
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Reva Schneider (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSan AntonioTexas78229
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
David Sommerhalder (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteTylerTexas75702
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Donald Richards (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteWest Valley CityUtah84119
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
William McKean (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNorfolkVirginia23502
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Jedrzej Wykretowicz (PRINCIPAL_INVESTIGATOR)

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