Actively Recruiting
A Phase 1b/2 Study to Evaluate the Safety and Effectiveness of GSK5764227 Alone and in Combination for Advanced Unresectable or Metastatic Gastrointestinal Cancers
Led by GlaxoSmithKline · Updated on 2025-11-18
320
Participants Needed
47
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new medicine called GSK5764227 to see how well it works, how safe it is, and how the body processes it in adults worldwide who have advanced gastrointestinal cancers that cannot be removed by surgery and who have already received treatment. This trial is a Phase 1b/2 study focusing on participants with advanced, unresectable, or metastatic gastrointestinal tumors, including colorectal and pancreatic adenocarcinomas. Participants will receive GSK5764227 alone or in combination with other treatments, with different dosing groups depending on the type of cancer. The study is randomized and open-label, meaning participants will be assigned to one of several dosing groups without blinding. Treatment effects, safety, and drug levels will be monitored over a period of up to about 37 months. Throughout the trial, participants will undergo regular assessments including tumor measurements, blood tests for organ function and drug levels, vital sign monitoring, and evaluation of side effects. Researchers will track tumor response, progression-free survival, adverse events, and changes in clinical and laboratory parameters. The total study participation may last up to approximately 37 months, including follow-up periods to assess long-term effects and safety.
CONDITIONS
Brief 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...
- Participants must be 18 years or older at the time of signing informed consent.
- For colorectal cancer (CRC) cohort: histologically confirmed unresectable or metastatic adenocarcinoma of colon or rectum.
- CRC participants must have received 1 to 2 lines of systemic treatment for advanced CRC with progression on the most recent therapy.
- For pancreatic cancer (PDAC) cohort: histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the pancreas.
- PDAC participants must have received exactly 1 line of therapy for advanced disease with documented progression.
- Participants must provide tumor tissue from a fresh biopsy or archival sample.
- Must have at least one target lesion per RECIST 1.1.
- Willing to use adequate contraception.
- Able to provide signed informed consent and comply with study requirements.
- ECOG performance status of 0 or 1.
- Adequate organ function as determined by the study.
You will not qualify if you...
- History of any malignancy other than the study disease that progressed or required treatment within the past 24 months, except certain skin or in-situ carcinomas.
- Major surgery within 28 days prior to randomization or first dose.
- Prior allogenic or autologous bone marrow or solid organ transplant.
- Known allergy or sensitivity to study drug components.
- Severe, uncontrolled cardiovascular disorders or serious hypertension.
- Significant bleeding issues within 1 month before first dose.
- Serious infection within 4 weeks before first dose.
- Active infectious diseases requiring treatment or known HIV.
- Serious thromboembolic events within 3 months prior to first dose.
- Untreated or progressing brain or CNS metastases.
- Current or recent pneumonitis requiring steroids or immunomodulatory treatment.
- Autoimmune disease requiring systemic treatment within 2 years prior to screening.
- Active renal conditions affecting safety.
- Ongoing adverse reactions from prior therapies not recovered to baseline.
- Serious or unstable medical or psychiatric conditions interfering with safety or compliance.
- Cirrhosis or unstable liver/biliary disease.
- Hepatitis B or C infection detected within 3 months before first dose.
- Recent immunosuppressive treatment within 30 days prior to first dose.
- Prior antibody-drug conjugate therapy with Topoisomerase-1 inhibitor.
- Live vaccine within 30 days before randomization or first dose.
- Participation in another investigational study or anticancer treatment within 4 weeks prior to randomization.
- Pregnancy or breastfeeding.
- Inability to follow study protocol and follow-up requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 37 months
Participants receive GSK5764227 alone or in combination with other treatments for advanced gastrointestinal cancers that cannot be surgically removed.
Regular visits for treatment and assessments during this period
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
Actively Recruiting
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
Actively Recruiting
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
E
EU GSK Clinical Trials Call Center
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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