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

NCT07277270 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 3001482025-522274-37-00
• Study Type: interventional
• Target: 84
• Locations: 3 countries
• Sites: 6

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

  Up to approximately 31 weeks

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

  Up to approximately 31 weeks

• Number of participants with dose limiting toxicities (DLTs)

  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

  Up to approximately 31 weeks

Secondary Outcomes (10)

• Plasma concentration of GSK5764227 [conjugated antibody and payload (GSK5757810)

  Up to approximately 112 weeks

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

  Up to approximately 112 weeks

• Number of participants with neutralising antibody (NAb) against GSK5764227

  Up to approximately 112 weeks

• Titer of ADA against GSK5764227

  Up to approximately 112 weeks

• Objective Response Rate (ORR)

  Up to approximately 112 weeks

Study Arms (3)

Metastatic colorectal cancer (mCRC) cohort A1

EXPERIMENTAL

Drug: GSK5764227; Drug: Bevacizumab

Metastatic colorectal cancer (mCRC) cohort A2

EXPERIMENTAL

Drug: GSK5764227; Drug: Bevacizumab; Drug: Fluorouracil; Drug: leucovorin

Metastatic castration-resistant prostate cancer (mCRPC) cohort B

EXPERIMENTAL

Drug: GSK5764227; Drug: Enzalutamide

Interventions

GSK5764227 DRUG

Participants will receive GSK5764227.

Metastatic castration-resistant prostate cancer (mCRPC) cohort B; Metastatic colorectal cancer (mCRC) cohort A1; Metastatic colorectal cancer (mCRC) cohort A2

Bevacizumab DRUG

Participants will receive bevacizumab.

Metastatic colorectal cancer (mCRC) cohort A1; Metastatic colorectal cancer (mCRC) cohort A2

Fluorouracil DRUG

Participants will receive fluorouracil.

Metastatic colorectal cancer (mCRC) cohort A2

leucovorin DRUG

Participants will receive leucovorin.

Metastatic colorectal cancer (mCRC) cohort A2

Enzalutamide DRUG

Participants will receive enzalutamide.

Metastatic castration-resistant prostate cancer (mCRPC) cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Lake Success, New York, 11042, United States

RECRUITING

GSK Investigational Site

Tugun, Queensland, 4224, Australia

RECRUITING

GSK Investigational Site

Barcelona, 08035, Spain

RECRUITING

GSK Investigational Site

Madrid, 28034, Spain

RECRUITING

GSK Investigational Site

Madrid, 28050, Spain

RECRUITING

GSK Investigational Site

Málaga, 29010, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms

Interventions

Bevacizumab; Fluorouracil; Leucovorin; enzalutamide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 11, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): September 29, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

ES (4); US (1); AU (1)