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GSK5764227

Phase 1

Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: Jan 7, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

GSK5764227 · 1 trial · 1 indication

Phase 1 1
NCT07277270A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid TumorsNeoplasms
RECRUITING84 Analytics
PHASE1RECRUITING
A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Metastatic colorectal cancer (mCRC) cohort A1EXPERIMENTAL -
Metastatic colorectal cancer (mCRC) cohort A2EXPERIMENTAL -
Metastatic castration-resistant prostate cancer (mCRPC) cohort BEXPERIMENTAL -

Interventions

NameTypeDescription
GSK5764227DRUGParticipants will receive GSK5764227.
BevacizumabDRUGParticipants will receive bevacizumab.
FluorouracilDRUGParticipants will receive fluorouracil.
leucovorinDRUGParticipants will receive leucovorin.
EnzalutamideDRUGParticipants will receive enzalutamide.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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) * Histologic...

Countries:United StatesAustraliaSpain
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Frequently asked questions about GSK5764227

What is GSK5764227 used for?

GSK5764227 is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently being studied in patients with advanced solid tumors as part of a Phase 1 clinical trial.

Who makes GSK5764227?

GSK5764227 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting a Phase 1 clinical trial to evaluate the drug in combination with standard of care or other agents in participants with advanced solid tumors.

What phase is GSK5764227 in?

GSK5764227 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being tested for safety and efficacy in humans. The ongoing Phase 1 trial is currently recruiting participants.

What clinical trials is GSK5764227 in?

GSK5764227 is being studied in a Phase 1 clinical trial with the identifier NCT07277270. This trial is titled 'A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors' and is currently recruiting participants in the United States, Australia, and Spain.

What is the enrollment and design of the GSK5764227 trial?

The Phase 1 trial of GSK5764227 (NCT07277270) has a planned enrollment of 84 participants aged 18 years and older. The trial is controlled but not randomized or double-blinded. It is open to all sexes and does not involve healthy volunteers.