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RECRUITING

NCT06885034

PHASE1/PHASE2

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 (EMBOLD PanGI-201)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study will check how well a new medicine, Risvutatug rezetecan, (Ris-Rez, also known as 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.

Official title: A Phase1 b/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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

451

Start Date

2025-06-11

Completion Date

2029-01-09

Last Updated

2026-08-03

Healthy Volunteers

Conditions

Gastrointestinal Neoplasms

Interventions

BIOLOGICAL

Risvutatug Rezetecan

Risvutatug Rezetecan will be administered

DRUG

Drug 1

Drug 1 will be administered

DRUG

Drug 2

Drug 2 will be administered

DRUG

Drug 3

Drug 3 will be administered

DRUG

Drug 4

Drug 4 will be administered

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.

Locations (85)

GSK Investigational Site

Los Alamitos, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Santa Monica, California, United States

GSK Investigational Site

Whittier, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Durham, North Carolina, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Wenatchee, Washington, United States

GSK Investigational Site

Madison, Wisconsin, United States

GSK Investigational Site

Heidelberg, Victoria, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Bonheiden, Belgium

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Leuven, Belgium

GSK Investigational Site

Roeselare, Belgium

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Teresina, Brazil

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Kuopio, Finland

GSK Investigational Site

Tampere, Finland

GSK Investigational Site

Dijon, France

GSK Investigational Site

Marseille, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Poitiers, France

GSK Investigational Site

Rennes, France

GSK Investigational Site

Villejuif, France

GSK Investigational Site

Bochum, Germany

GSK Investigational Site

Düsseldorf, Germany

GSK Investigational Site

Frankfurt, Germany

GSK Investigational Site

Lübeck, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Pisa, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tuxtla Gutiérrez, Chiapas, Mexico

GSK Investigational Site

Cuernavaca, Morelos, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

San Pedro Garza García, Mexico

GSK Investigational Site

Amsterdam, Netherlands

GSK Investigational Site

Maastricht, Netherlands

GSK Investigational Site

Rotterdam, Netherlands

GSK Investigational Site

Utrecht, Netherlands

GSK Investigational Site

Lrenskog, Norway

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Stavanger, Norway

GSK Investigational Site

La Villa de Los Santos, Los Santos Province, Panama

GSK Investigational Site

Punta Pacifica Panama City Panama, Panama

GSK Investigational Site

Brzozów, Poland

GSK Investigational Site

Koszalin, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Seoul, Seoul Teugbyeolsi, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

HebrOn, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Pamplona, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Gothenburg, Sweden

GSK Investigational Site

Lund, Sweden

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Uppsala, Sweden

GSK Investigational Site

Manchester, United Kingdom

Clinical Research Directory

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 (EMBOLD PanGI-201)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (85)