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

November 17, 2025 updated by: GlaxoSmithKline

A Phase 1b/2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Niall Tebbutt
        • Contact:
        • Contact:
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeanne Tie
  • Belgium
      • Bonheiden, Belgium, 2820
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pieter-Jan Cuyle
      • Brussels, Belgium, 1200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marc Van den Eynde
        • Contact:
        • Contact:
      • Leuven, Belgium, 3000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gertjan Rasschaert
      • Roeselare, Belgium, 8800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sofie De Meulder
  • Brazil
      • Porto Alegre, Brazil, 90850-170
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alan Arrieira Azambuja
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Camila Moniz
      • Teresina, Brazil, 64049-200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudio Henrique Lima Rocha
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Chen
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Frederic Lemay
        • Contact:
        • Contact:
  • France
      • Paris, France, 75012
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thierry Andre
        • Contact:
        • Contact:
      • Paris, France, 75010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thomas APARICIO
        • Contact:
        • Contact:
      • Villejuif, France, 94805
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michel Ducreux
        • Contact:
        • Contact:
  • Italy
      • Pisa, Italy, 56126
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Chiara Cremolini
        • Contact:
        • Contact:
  • Japan
      • Aichi, Japan, 464-8681
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kei Muro
        • Contact:
        • Contact:
      • Chiba, Japan, 277-8577
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Akihito Kawazoe
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshito Komatsu
      • Osaka, Japan, 565-0871
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Taroh Satoh
        • Contact:
        • Contact:
      • Tokyo, Japan, 104-0045
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Toshiharu Hirose
      • Tokyo, Japan, 135-8550
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kensei Yamaguchi
        • Contact:
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marieke A. Vollebergh
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Jan Kwakman
  • Norway
      • Lrenskog, Norway, 1474
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Asa Dahle-Smith
        • Contact:
        • Contact:
      • Oslo, Norway, 0407
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorgen Smeby
      • Stavanger, Norway, 4011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Herish Garresori
  • Poland
      • Brzozów, Poland, 36-200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joanna Kiszka
      • Warsaw, Poland, 02-034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucjan Wyrwicz
  • South Korea
      • Seoul, South Korea, 138-736
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yong Sang Hong
      • Seoul, South Korea, 110 744
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sae-Won Han
      • Seoul, South Korea, 135-710
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seung Tae Kim
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Paez Lopez-Bravo
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Íñigo Martínez Delfrade
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Del Carmen Riesco Martinez
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pilar Garcia Alfonso
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ruth Vera Garcìa
        • Contact:
        • Contact:
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos Lopez Lopez
      • Zaragoza, Spain, 50009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vicente Alonso Orduna
  • Sweden
      • Lund, Sweden, 22185
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jakob Eberhard
      • Stockholm, Sweden, SE-118 83
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Virginia Alvariza
  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Vu Phan
        • Contact:
        • Contact:
      • Whittier, California, United States, 90602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Pham
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Andrea Cercek
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicholas DeVito
    • Texas
      • Houston, Texas, United States, 77479
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kanwal Raghav
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Drew W Rasco
        • Contact:
        • Contact:
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lindsay Overton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

• Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF).

CRC Cohort

  • Has histologically confirmed unresectable/, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification).
  • Must have received at least 1 and no more than 2 lines of systemic treatment for advanced colorectal cancer (CRC), with documented progression on most recent prior line of therapy.
  • Must provide tumor tissue from a newly obtained fresh biopsy or an archival tumor tissue.

PDAC Cohort

  • Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).
  • Must have received 1 and no more than 1 line of therapy for advanced PDAC, with documented progression.
  • Should provide tumor tissue at screening, where available or medically feasible.

All Cohorts

  • Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
  • Is willing to use adequate contraception.
  • Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
  • Has an ECOG performance status of 0 or 1.
  • Has adequate organ function.

Exclusion criteria:

Participants are excluded from the study if any of the following criteria apply:

  • 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 randomization (CRC Cohort) or first dose of study intervention (PDAC Cohort).
  • Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
  • Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
  • Has severe, uncontrolled or active cardiovascular disorders.
  • Has serious or poorly controlled hypertension.
  • 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.
  • Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
  • Has serious arteriovenous thromboembolic events (such as deep vein thrombosis, pulmonary embolism, etc.) within 3 months prior to the first dose.
  • Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
  • Has current active pneumonitis or any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned [randomization] or any history of drug-induced pneumonitis.
  • Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.
  • Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).
  • Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy.
  • Has any serious and/or unstable medical or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.
  • Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
  • Has documented presence of Hepatitis B surface antigen (HBsAg) or HBcAb at screening or within 3 months prior to the first dose of study intervention.
  • Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to the first dose of study intervention.
  • Has a positive HCV RNA test result at screening or within 3 months prior to the first dose of study intervention.
  • Has received immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term [30 days or longer]).
  • Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload.
  • Has received any live vaccine within 30 days of randomization (CRC Cohort) or before first dose of study intervention (PDAC Cohort).
  • Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type of interventional medical research and/or has received treatment with any anticancer or investigational agent within 4 weeks prior to randomization.
  • Is pregnant or breastfeeding.
  • Is unable to adhere to the protocol defined SoA, including requirements for the Follow-up Period of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRC-A: GSK5764227 (Dose 1)
Biological: GSK5764227
GSK5764227 will be administered
Experimental: CRC-A: GSK5764227 (Dose 2)
Biological: GSK5764227
GSK5764227 will be administered
Experimental: CRC-B: GSK5764227 (Dose 3)
Biological: GSK5764227
GSK5764227 will be administered
Experimental: CRC-B: GSK5764227 (Dose 4)
Biological: GSK5764227
GSK5764227 will be administered
Experimental: PDAC: GSK5764227 (Dose 5)
Biological: GSK5764227
GSK5764227 will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed Objective Response Rate (ORR)
Time Frame: Up to approximately 22 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)
Up to approximately 22 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unconfirmed ORR
Time Frame: Up to approximately 37 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.
Up to approximately 37 months
Duration of Response (DoR)
Time Frame: Up to approximately 37 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.
Up to approximately 37 months
Progression Free Survival (PFS)
Time Frame: Up to approximately 37 months
PFS (assessed by investigator), defined as the time from date of randomization (for participants in CRC-A and CRC-B) or the date of first dose study intervention for participants in PDAC until the earliest date of documented disease progression per RECIST 1.1 or death due to any cause.
Up to approximately 37 months
Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity
Time Frame: Up to approximately 37 months
Up to approximately 37 months
Number of participants with AEs leading to dose modifications, discontinuation of study interventions or death
Time Frame: Up to approximately 37 months
Up to approximately 37 months
Changes from baseline in vital signs: Temperature (degree Celsius)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline vital signs: Respiratory rate (breaths per minute)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline vital signs: Pulse rate (beats per minute)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline vital signs: Blood pressure [millimetres of mercury (mmHg)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline in hematology parameters: [White blood cell count (WBCs per microliter)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline in hematology parameters: [Haemoglobin (Hgb) (grams per deciliter)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline in hematology parameters:[Haematocrit (Proportion of red blood cells in blood)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from Baseline haematology parameter: [Red Blood Cell Count (RBC) (million cells per microliter)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from Baseline haematology parameter: Platelet count (cells per microliter)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical chemistry parameters: Total Protein, Albumin (Grams per deciliter)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Time Frame: Baseline (Day 1) and up to approximately 37 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
Baseline (Day 1) and up to approximately 37 months
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)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical Chemistry parameters: Lactate dehydrogenase, Amylase and Lipase (units per liter)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical Chemistry parameters: Chloride (millimoles per liter)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical Chemistry parameters: Creatinine clearance (milliliters per minute)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline cardiac function: Electrocardiogram (ECG) (milliseconds)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Changes from baseline Eastern Cooperative Oncology Group performance status (ECOG-PS)
Time Frame: Baseline (Day 1) and up to approximately 37 months
Baseline (Day 1) and up to approximately 37 months
Maximum observed concentration (Cmax) of GSK5764227 (conjugated antibody) and GSK5757810 (small molecule toxin)
Time Frame: Up to approximately 37 months
Up to approximately 37 months
Time to reach Cmax (Tmax) of GSK5764227 (conjugated antibody) and GSK5757810 (small molecule toxin)
Time Frame: Up to approximately 37 months
Up to approximately 37 months
Area under the concentration-time curve (AUC) of GSK5764227 (conjugated antibody) and GSK5757810 (small molecule toxin)
Time Frame: Up to approximately 37 months
Up to approximately 37 months
Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)
Time Frame: Up to approximately 37 months
Up to approximately 37 months
Titers of ADA against GSK5764227
Time Frame: Up to approximately 37 months
Up to approximately 37 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)
Time Frame: Up to approximately 37 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
Up to approximately 37 months
Level of bother of AEs as measured by Functional Assessment of Cancer Therapy - Item GP5 (FACT-GP5)
Time Frame: Up to approximately 37 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.
Up to approximately 37 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2025

Primary Completion (Estimated)

November 11, 2027

Study Completion (Estimated)

June 23, 2028

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223675
  • 2025-520672-26 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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