A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed

Phase 1

Not yet recruiting

• Conditions: Gastrointestinal Neoplasms
• Interventions: Biological: GSK5764227

• Registration Number: NCT06885034
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will check how well a new medicine, GSK5764227, works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Study Start: 2025-06-30
• Primary Completion: 2026-11-30
• Study Completion: 2028-03-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSK5764227 (low dose)	GSK5764227	-
GSK5764227(high dose)	GSK5764227	-

Primary Outcome Measures

Name	Time	Method
Confirmed Objective Response Rate (ORR)	Up to approximately 17 months	Confirmed ORR is defined as the proportion of participants who have achieved best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by investigator, according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Secondary Outcome Measures

Name	Time	Method
Unconfirmed ORR	Up to approximately 32 months	Unconfirmed ORR is defined as the proportion of participants who have achieved a BOR of CR or PR as assessed by investigator, according to RECIST 1.1.
Duration of Response (DoR)	Up to approximately 32 months	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) until the date of the first documented progressive disease (PD) or death, whichever is earlier.
Progression Free Survival (PFS)	Up to approximately 32 months	PFS (assessed by investigator), defined as the time from date of randomization until the earliest date of documented disease progression per RECIST 1.1 or death due to any cause.
Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity	Up to approximately 32 months
Number of participants with AEs leading to dose modifications, discontinuation of study interventions or death	Up to approximately 32 months
Changes from baseline in vital signs: Temperature (degree Celsius)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline vital signs: Respiratory rate (breaths per minute)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline vital signs: Pulse rate (beats per minute)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline vital signs: Blood pressure [millimetres of mercury (mmHg)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline in hematology parameters: [White blood cell count (WBCs per microliter)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline in hematology parameters: [Haemoglobin (Hgb) (grams per deciliter)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline in hematology parameters:[Haematocrit (Proportion of red blood cells in blood)	Baseline (Day 1) and up to approximately 32 months
Changes from Baseline haematology parameter: [Red Blood Cell Count (RBC) (million cells per microliter)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)	Baseline (Day 1) and up to approximately 32 months
Changes from Baseline haematology parameter: Platelet count (cells per microliter)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline Clinical chemistry parameters: Total Protein, Albumin (Grams per deciliter)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)	Baseline (Day 1) and up to approximately 32 months	Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
Changes from baseline Clinical Chemistry parameters: Total Bilirubin and Direct Bilirubin, Glucose, Calcium, Potassium, Sodium, Magnesium, Urea Nitrogen or urea, and Creatinine (milligrams per deciliter)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline Clinical Chemistry parameters: Lactate dehydrogenase, Amylase and Lipase (units per liter)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline Clinical Chemistry parameters: Chloride (millimoles per liter)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline Clinical Chemistry parameters: Creatinine clearance (milliliters per minute)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline cardiac function: Electrocardiogram (ECG) (milliseconds)	Baseline (Day 1) and up to approximately 32 months
Changes from baseline Eastern Cooperative Oncology Group performance status (ECOG-PS)	Baseline (Day 1) and up to approximately 32 months
Maximum observed concentration (Cmax) of GSK5764227 (conjugated antibody and small molecule toxin)	Up to approximately 32 months
Time to reach Cmax (Tmax) of GSK5764227 (conjugated antibody and small molecule toxin)	Up to approximately 32 months
Area under the concentration-time curve (AUC) of GSK5764227 (conjugated antibody and small molecule toxin)	Up to approximately 32 months
Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)	Up to approximately 32 months
Titers of ADA against GSK5764227	Up to approximately 32 months
Number of participants with symptomatic AEs, by severity, as measured by Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	Up to approximately 32 months	The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes a library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE
Level of bother of AEs as measured by Functional Assessment of Cancer Therapy - Item GP5 (FACT-GP5)	Up to approximately 32 months	The FACT-GP5 item is a single item from the FACT-G that assesses how bothersome the side effects of treatment are for cancer patients. The item has a 5-category response scale ranging from 0 to 4. Higher scores indicate a higher degree of AE bother.