Recruiting

Phase 1

GSK5764227 with Standard TreatmentsA Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

Sponsor:

GlaxoSmithKline

Code:

NCT07277270

Conditions

Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GSK5764227

Bevacizumab

Fluorouracil

leucovorin

Enzalutamide

Study Details

Brief summary:

The goal of this clinical trial is to test a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, and assess whether it can shrink or control cancer.

Conditions

Neoplasms

Study ID

NCT07277270

Start date

Dec 3, 2025

Status verified date

Sep, 2026

Completion date

May 1, 2030

Anticipated

Primary completion date

Feb 14, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
Has adequate organ function.
Has histologically confirmed unresectable adenocarcinoma or unresectable metastatic adenocarcinoma of the colon or rectum. (Cohort A)
Histologically or cytologically confirmed adenocarcinoma of the prostate (Cohort B)

Exclusion Criteria:

Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of disease.
Has had any major surgery within 28 days prior to first dose.
Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
Has serious infection within 4 weeks prior to the first dose,
Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
Any evidence of current interstitial lung disease (ILD) or pneumonitis OR a prior history of ILD requiring high-dose glucocorticoids or non-infectious pneumonitis requiring high-dose glucocorticoids.
Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.
Has received immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term \[30 days or longer\]). Low-dose corticosteroids (prednisone ≤10 milligrams (mg)/day or equivalent) may be administered.

Study Design

Enrollment

83 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Metastatic colorectal cancer (mCRC) cohort A1

experimental: Metastatic colorectal cancer (mCRC) cohort A2

experimental: Metastatic castration-resistant prostate cancer (mCRPC) cohort B

Interventions

GSK5764227

Participants will receive GSK5764227.

Bevacizumab

Participants will receive bevacizumab.

Fluorouracil

Participants will receive fluorouracil.

leucovorin

Participants will receive leucovorin.

Enzalutamide

Participants will receive enzalutamide.

Primary outcome measure

Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modifications [ Time Frame: Up to approximately 31 weeks ]
Number of participants with AEs, SAEs, AESIs, and AEs leading to dose modifications by severity [ Time Frame: Up to approximately 31 weeks ]
Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to approximately 31 weeks ]
Number of participants with clinically significant changes in Vital Signs, Body Weight, Laboratory Tests [Hematology, Clinical Chemistry, Urinalysis], Cardiac Function [ECG], and Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Up to approximately 31 weeks ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Reunion, Florida, United States, 34747-4606

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Guru Sonpavde

GSK Investigational Site

Recruiting

New Hyde Park, New York, United States, 11042-1118

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Geraldine O'Sullivan Coyne

GSK Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Babar Bashir

GSK Investigational Site

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Benjamin Garmezy

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75230

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Reva Schneider

GSK Investigational Site

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

John Hilton

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Abdulazeez Salawu

More Information

Sponsor

GlaxoSmithKline

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

Solid Tumors
Metastatic colorectal cancer
Metastatic castration-resistant prostate cancer
GSK5764227
Bevacizumab
Fluorouracil
Folinic acid
Enzalutamide
EMBOLD
EMBOLD PanTumor-102

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.