Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2025-11-18
320
Participants Needed
47
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old or the legal age of consent where the study takes place
- For colorectal cancer (CRC) group: have confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
- For CRC group: have received 1 to 2 lines of systemic treatment for advanced colorectal cancer with progression after the most recent treatment
- For CRC group: provide tumor tissue from a recent biopsy or archival sample
- For pancreatic cancer (PDAC) group: have confirmed unresectable or metastatic adenocarcinoma of the pancreas
- For PDAC group: have received exactly 1 line of therapy for advanced pancreatic cancer with progression
- Provide tumor tissue at screening if medically possible
- Have at least one target lesion according to RECIST 1.1 criteria
- Willing to use adequate contraception
- Able to give signed informed consent and comply with study requirements
- Have an ECOG performance status of 0 or 1
- Have adequate organ function
You will not qualify if you...
- Have any other cancer that has progressed or needed treatment in the past 24 months except certain skin or in-situ carcinomas fully removed
- Had major surgery within 28 days before starting the study treatment
- History of bone marrow or solid organ transplant
- Known allergies to study treatment components or excipients that contraindicate participation
- Severe, uncontrolled cardiovascular disease or poorly controlled high blood pressure
- Significant bleeding symptoms or bleeding tendency within 1 month before treatment
- Serious infection within 4 weeks before treatment
- Active infections requiring treatment or known HIV infection
- Serious blood clots within 3 months before treatment
- Untreated or progressing brain or central nervous system metastases
- Active pneumonitis or history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days
- Autoimmune disease requiring systemic treatment in past 2 years
- Active kidney problems such as infection or need for dialysis
- Ongoing adverse reactions from prior therapy not recovered to mild or baseline
- Serious or unstable medical or psychiatric conditions that could affect safety or compliance
- Liver disease or cirrhosis with complications
- Positive tests for Hepatitis B or C within 3 months before treatment
- Use of immunosuppressive agents within 30 days before treatment or requiring long-term use
- Prior treatment with antibody-drug conjugates containing Topoisomerase-1 inhibitors
- Received live vaccines within 30 days before starting treatment
- Participation in other clinical trials or anticancer treatments within 4 weeks before starting
- Pregnant or breastfeeding
- Unable to follow study procedures including follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
GSK Investigational Site
Los Alamitos, California, United States, 90720
Actively Recruiting
2
GSK Investigational Site
Whittier, California, United States, 90602
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3
GSK Investigational Site
New York, New York, United States, 10065
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4
GSK Investigational Site
Durham, North Carolina, United States, 27710
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5
GSK Investigational Site
Houston, Texas, United States, 77479
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6
GSK Investigational Site
San Antonio, Texas, United States, 78229
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7
GSK Investigational Site
Wenatchee, Washington, United States, 98801
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8
GSK Investigational Site
Heidelberg, Victoria, Australia, 3084
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9
GSK Investigational Site
Melbourne, Victoria, Australia, 3000
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10
GSK Investigational Site
Bonheiden, Belgium, 2820
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11
GSK Investigational Site
Brussels, Belgium, 1200
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12
GSK Investigational Site
Leuven, Belgium, 3000
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13
GSK Investigational Site
Roeselare, Belgium, 8800
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14
GSK Investigational Site
Porto Alegre, Brazil, 90850-170
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15
GSK Investigational Site
São Paulo, Brazil, 01246-000
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16
GSK Investigational Site
Teresina, Brazil, 64049-200
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17
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
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18
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
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19
GSK Investigational Site
Paris, France, 75010
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20
GSK Investigational Site
Paris, France, 75012
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21
GSK Investigational Site
Villejuif, France, 94805
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22
GSK Investigational Site
Pisa, Italy, 56126
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23
GSK Investigational Site
Aichi, Japan, 464-8681
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24
GSK Investigational Site
Chiba, Japan, 277-8577
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25
GSK Investigational Site
Hokkaido, Japan, 060-8648
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26
GSK Investigational Site
Osaka, Japan, 565-0871
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27
GSK Investigational Site
Tokyo, Japan, 104-0045
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28
GSK Investigational Site
Tokyo, Japan, 135-8550
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29
GSK Investigational Site
Amsterdam, Netherlands, 1066 CX
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30
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
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31
GSK Investigational Site
Lrenskog, Norway, 1474
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32
GSK Investigational Site
Oslo, Norway, 0407
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33
GSK Investigational Site
Stavanger, Norway, 4011
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34
GSK Investigational Site
Brzozów, Poland, 36-200
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35
GSK Investigational Site
Warsaw, Poland, 02-034
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36
GSK Investigational Site
Seoul, South Korea, 110 744
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37
GSK Investigational Site
Seoul, South Korea, 135-710
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38
GSK Investigational Site
Seoul, South Korea, 138-736
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39
GSK Investigational Site
Barcelona, Spain, 08041
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40
GSK Investigational Site
Madrid, Spain, 28007
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41
GSK Investigational Site
Madrid, Spain, 28034
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42
GSK Investigational Site
Madrid, Spain, 28041
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43
GSK Investigational Site
Pamplona, Spain, 31008
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44
GSK Investigational Site
Santander, Spain, 39011
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45
GSK Investigational Site
Zaragoza, Spain, 50009
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46
GSK Investigational Site
Lund, Sweden, 22185
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47
GSK Investigational Site
Stockholm, Sweden, SE-118 83
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Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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