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NeoplasmsPhase 1NCT07277270

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

A Phase 1 study testing GSK5764227, Bevacizumab and Fluorouracil in people with Neoplasms, run by GlaxoSmithKline at 22 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
GSK5764227, Bevacizumab and Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
22 sitesin 6 countries
Study dates
3 Dec 2025to 1 May 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

22 sites in 6 countries

United States5 sites, 5 recruiting
  • GSK Investigational Site

    Dallas, Texas, 75230

    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

    Recruiting
  • GSK Investigational Site

    Nashville, Tennessee, 37203

    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

    Recruiting
  • GSK Investigational Site

    New Hyde Park, New York, 11042-1118

    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

    Recruiting
  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

    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

    Recruiting
  • GSK Investigational Site

    Reunion, Florida, 34747-4606

    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

    Recruiting

Other trials in United States

Spain5 sites, 5 recruiting
  • GSK Investigational Site

    Barcelona, 08035

    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

    Recruiting
  • GSK Investigational Site

    Madrid, 28034

    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

    Recruiting
  • GSK Investigational Site

    Madrid, 28040

    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

    Recruiting
  • GSK Investigational Site

    Madrid, 28050

    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

    Recruiting
  • GSK Investigational Site

    Málaga, 29010

    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

    Recruiting

Other trials in Spain

Australia4 sites, 4 recruiting
  • GSK Investigational Site

    Bendigo, VIC 3550

    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

    Recruiting
  • GSK Investigational Site

    Douglas, Queensland, 4814

    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

    Recruiting
  • GSK Investigational Site

    Geelong, Victoria, 3220

    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

    Recruiting
  • GSK Investigational Site

    Tugun, Queensland, 4224

    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

    Recruiting

Other trials in Australia

South Korea3 sites, 3 recruiting
  • GSK Investigational Site

    Seoul, 03722

    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

    Recruiting
  • GSK Investigational Site

    Seoul, 06351

    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

    Recruiting
  • GSK Investigational Site

    Seoul, 138-736

    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

    Recruiting

Other trials in South Korea

United Kingdom3 sites, 3 recruiting
  • GSK Investigational Site

    Leicester, LE1 5WW

    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

    Recruiting
  • GSK Investigational Site

    London, W12 0NN

    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

    Recruiting
  • GSK Investigational Site

    Sutton, SM2 5PT

    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

    Recruiting

Other trials in United Kingdom

Canada2 sites, 2 recruiting
  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

    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

    Recruiting
  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

    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

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

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
Being tested
GSK5764227, Bevacizumab, Fluorouracil, leucovorin, Enzalutamide
Keywords
Solid Tumors, Metastatic colorectal cancer, Metastatic castration-resistant prostate cancer, GSK5764227, Bevacizumab, Fluorouracil, Folinic acid, Enzalutamide, EMBOLD, EMBOLD PanTumor-102
Medical subject headings
Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK5764227Drug

    Participants will receive GSK5764227.

  • BevacizumabDrug

    Participants will receive bevacizumab.

  • FluorouracilDrug

    Participants will receive fluorouracil.

  • leucovorinDrug

    Participants will receive leucovorin.

  • EnzalutamideDrug

    Participants will receive enzalutamide.

Study groups in NCT07277270
Study groupRoleWhat they receive
Metastatic colorectal cancer (mCRC) cohort A1ExperimentalNot described
Receives: Drug: GSK5764227; Drug: Bevacizumab
Metastatic colorectal cancer (mCRC) cohort A2ExperimentalNot described
Receives: Drug: GSK5764227; Drug: Bevacizumab; Drug: Fluorouracil; Drug: leucovorin
Metastatic castration-resistant prostate cancer (mCRPC) cohort BExperimentalNot described
Receives: Drug: GSK5764227; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modifications

    Measured: Up to approximately 31 weeks

  2. Number of participants with AEs, SAEs, AESIs, and AEs leading to dose modifications by severity

    Measured: Up to approximately 31 weeks

  3. Number of participants with dose limiting toxicities (DLTs)

    Measured: Up to approximately 31 weeks

  4. 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

    Measured: Up to approximately 31 weeks

Secondary outcomes (10)
  1. Plasma concentration of GSK5764227 [conjugated antibody and payload (GSK5757810)

    Measured: Up to approximately 112 weeks

  2. Number of participants with anti-drug antibody (ADA) against GSK5764227

    Measured: Up to approximately 112 weeks

  3. Number of participants with neutralising antibody (NAb) against GSK5764227

    Measured: Up to approximately 112 weeks

  4. Titer of ADA against GSK5764227

    Measured: Up to approximately 112 weeks

  5. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants who have achieved best observed response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for Cohort A or per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) for Cohort B.

    Measured: Up to approximately 112 weeks

  6. Disease control Rate (DCR18)

    DCR18 is defined as the proportion of participants who have achieved CR or PR, or stable disease (SD) of ≥17 weeks as assessed by investigator according to PCWG3 for Cohort B.

    Measured: Up to approximately 112 weeks

  7. Duration of Response (DoR)

    DOR is defined as the time from the date of the first documented objective response (CR/PR) as assessed by investigator according to RECIST 1.1 for cohort A or PCWG3 for cohort B, until the date of the first documented disease progression (PD) or death due to any cause, whichever is earlier.

    Measured: Up to approximately 112 weeks

  8. Progression free survival (PFS)

    PFS is defined as the time from the date of first dose until the earliest date of documented disease progression as assessed by investigator according to RECIST 1.1 for cohort A.

    Measured: Up to approximately 112 weeks

  9. Radiographic progression-free survival (rPFS)

    rPFS is defined as the time from the date of first dose until the earliest date of documented PD per PCWG3-modified RECIST 1.1 (soft tissue lesion assessment) and/or PCWG3 bone lesion assessment for cohort B or death due to any cause.

    Measured: Up to approximately 112 weeks

  10. Prostate-specific antigen 50 (PSA50)

    PSA50 is defined as percentage of participants with a decrease of >=50% in the PSA concentration from the baseline PSA value, confirmed at least 3 weeks later (cohort B)

    Measured: Up to approximately 112 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start3 Dec 2025
  3. Primary completion14 Feb 2028 (estimated)
  4. Study completion1 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07277270
Sponsor's protocol ID
300148
Other IDs
2025-522274-37-00, 2025
Status last verified
Sep 2026
First submitted
2 Dec 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK5764227, Bevacizumab and Fluorouracil in people with Neoplasms, run by GlaxoSmithKline at 22 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Spain, Australia, South Korea, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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