A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers... | NCT06885034 | Trialant

A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers... | NCT06885034 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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).

PDAC Cohort

Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).

All Cohorts

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 or first dose of study intervention, depending on sub-cohort/cohort assignment

Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.

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 untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed.

Has evidence of current ILD/non-infectious pneumonitis or a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids Or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging.

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 received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload.

Is pregnant or breastfeeding.

GSK Investigational SiteRecruiting

Los Alamitos, California 90505, United States

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

EU GSK Clinical Trials Call CentreContact

GSKClinicalSupportHD@gsk.com+44 (0) 20 8990 4466

Vu PhanPrincipal Investigator

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Los Angeles, California 90089, United States

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Santa Monica, California 90404, United States

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Whittier, California 90602, United States

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Aurora, Colorado 80045, United States

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New York, New York 10021, United States

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New York, New York 10065, United States

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Durham, North Carolina 27710, United States

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Houston, Texas 77479, United States

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San Antonio, Texas 78229, United States

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Wenatchee, Washington 98801, United States

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Madison, Wisconsin 53792-0001, United States

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Heidelberg, Victoria 3084, Australia

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Melbourne, Victoria 3000, Australia

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Bonheiden, 2820, Belgium

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Brussels, 1200, Belgium

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Leuven, 3000, Belgium

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Roeselare, 8800, Belgium

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Porto Alegre, 90850-170, Brazil

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São Paulo, 01246-000, Brazil

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Teresina, 64049-200, Brazil

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Calgary, Alberta T2N 5G2, Canada

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Toronto, Ontario M5G 2M9, Canada

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Montreal, Quebec H2X 0C1, Canada

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Sherbrooke, Quebec J1H 5N4, Canada

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Helsinki, 00029, Finland

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Helsinki, 00180, Finland

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Kuopio, 70210, Finland

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Tampere, 33520, Finland

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Dijon, 21079, France

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Marseille, 13273, France

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Paris, 75010, France

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Paris, 75012, France

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Paris, 75015, France

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Poitiers, 86021, France

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Rennes, 35042, France

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Villejuif, 94805, France

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Bochum, 44791, Germany

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Düsseldorf, 40225, Germany

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Frankfurt, 60488, Germany

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Lübeck, 23562, Germany

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München, 81737, Germany

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Milan, 20133, Italy

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Milan, 20162, Italy

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Pisa, 56126, Italy

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Roma, 00168, Italy

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Aichi, 464-8681, Japan

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Chiba, 277-8577, Japan

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Hokkaido, 060-8648, Japan

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

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Osaka, 565-0871, Japan

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Tokyo, 104-0045, Japan

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Tokyo, 135-8550, Japan

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Tuxtla Gutiérrez, Chiapas 29090, Mexico

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Cuernavaca, Morelos 62448, Mexico

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Mexico City, 03100, Mexico

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Mexico City, 06100, Mexico

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San Pedro Garza García, 66260, Mexico

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Amsterdam, 1066 CX, Netherlands

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Maastricht, 6229 HX, Netherlands

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Rotterdam, 3015 GD, Netherlands

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Utrecht, 3584 CX, Netherlands

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Lrenskog, 1474, Norway

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

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Oslo, 0407, Norway

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Stavanger, 4011, Norway

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La Villa de Los Santos, Los Santos Province 6040, Panama

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Punta Pacifica Panama City Panama, Panama

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

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Brzozów, 36-200, Poland

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Koszalin, 75-581, Poland

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Warsaw, 02-034, Poland

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Seoul, Seoul Teugbyeolsi 110 744, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Barcelona, 08041, Spain

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HebrOn, 08035, Spain

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Pamplona, 31008, Spain

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Santander, 39011, Spain

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Zaragoza, 50009, Spain

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Gothenburg, SE-413 45, Sweden

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Lund, 22185, Sweden

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Stockholm, SE-118 83, Sweden

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Uppsala, 751 85, Sweden

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Manchester, M20 4BX, United Kingdom