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)

NCT06885034 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2236752025-520672-26-00
• Study Type: interventional
• Target: 451
• Locations: 19 countries
• Sites: 85

Brief 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.

Conditions

Gastrointestinal Neoplasms

Keywords

GSK5764227; Risvutatug Rezetecan; Ris-Rez; Solid Tumors; Colorectal Cancer; Pancreatic ductal adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Confirmed Objective Response Rate (ORR)

  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 Outcomes (30)

• Unconfirmed ORR

  Up to approximately 37 months

• Duration of Response (DoR)

  Up to approximately 37 months

• Progression Free Survival (PFS)

  Up to approximately 37 months

• Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity

  Up to approximately 37 months

• Number of participants with AEs leading to dose modifications, discontinuation of study interventions or death

  Up to approximately 37 months

Study Arms (9)

CRC-A: Risvutatug Rezetecan (Dose 1)

EXPERIMENTAL

Biological: Risvutatug Rezetecan

CRC-A: Risvutatug Rezetecan (Dose 2)

EXPERIMENTAL

Biological: Risvutatug Rezetecan

CRC-B: Risvutatug Rezetecan (Dose 3)

EXPERIMENTAL

Biological: Risvutatug Rezetecan

CRC-B: Risvutatug Rezetecan (Dose 4)

EXPERIMENTAL

Biological: Risvutatug Rezetecan

CRC-C: Risvutatug Rezetecan (Dose 3) + Drug 1

EXPERIMENTAL

Biological: Risvutatug Rezetecan; Drug: Drug 1

CRC-D: Risvutatug Rezetecan (Dose 3) + Drug 1 + Drug 2 / Drug 3

EXPERIMENTAL

Biological: Risvutatug Rezetecan; Drug: Drug 1; Drug: Drug 2; Drug: Drug 3

CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4

EXPERIMENTAL

Biological: Risvutatug Rezetecan; Drug: Drug 4

CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4 + Drug 1

EXPERIMENTAL

Biological: Risvutatug Rezetecan; Drug: Drug 1; Drug: Drug 4

PDAC: Risvutatug Rezetecan (Dose 1)

EXPERIMENTAL

Biological: Risvutatug Rezetecan

Interventions

Risvutatug Rezetecan BIOLOGICAL

Risvutatug Rezetecan will be administered

CRC-A: Risvutatug Rezetecan (Dose 1); CRC-A: Risvutatug Rezetecan (Dose 2); CRC-B: Risvutatug Rezetecan (Dose 3); CRC-B: Risvutatug Rezetecan (Dose 4); CRC-C: Risvutatug Rezetecan (Dose 3) + Drug 1; CRC-D: Risvutatug Rezetecan (Dose 3) + Drug 1 + Drug 2 / Drug 3; CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4; CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4 + Drug 1; PDAC: Risvutatug Rezetecan (Dose 1)

Drug 1 DRUG

Drug 1 will be administered

CRC-C: Risvutatug Rezetecan (Dose 3) + Drug 1; CRC-D: Risvutatug Rezetecan (Dose 3) + Drug 1 + Drug 2 / Drug 3; CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4 + Drug 1

Drug 2 DRUG

Drug 2 will be administered

CRC-D: Risvutatug Rezetecan (Dose 3) + Drug 1 + Drug 2 / Drug 3

Drug 3 DRUG

Drug 3 will be administered

CRC-D: Risvutatug Rezetecan (Dose 3) + Drug 1 + Drug 2 / Drug 3

Drug 4 DRUG

Drug 4 will be administered

CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4; CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4 + Drug 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (85)

GSK Investigational Site

Los Alamitos, California, 90505, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90089, United States

RECRUITING

GSK Investigational Site

Santa Monica, California, 90404, United States

RECRUITING

GSK Investigational Site

Whittier, California, 90602, United States

RECRUITING

GSK Investigational Site

Aurora, Colorado, 80045, United States

RECRUITING

GSK Investigational Site

New York, New York, 10021, United States

RECRUITING

GSK Investigational Site

New York, New York, 10065, United States

RECRUITING

GSK Investigational Site

Durham, North Carolina, 27710, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77479, United States

RECRUITING

GSK Investigational Site

San Antonio, Texas, 78229, United States

RECRUITING

GSK Investigational Site

Wenatchee, Washington, 98801, United States

RECRUITING

GSK Investigational Site

Madison, Wisconsin, 53792-0001, United States

RECRUITING

GSK Investigational Site

Heidelberg, Victoria, 3084, Australia

RECRUITING

GSK Investigational Site

Melbourne, Victoria, 3000, Australia

RECRUITING

GSK Investigational Site

Bonheiden, 2820, Belgium

RECRUITING

GSK Investigational Site

Brussels, 1200, Belgium

RECRUITING

GSK Investigational Site

Leuven, 3000, Belgium

RECRUITING

GSK Investigational Site

Roeselare, 8800, Belgium

RECRUITING

GSK Investigational Site

Porto Alegre, 90850-170, Brazil

RECRUITING

GSK Investigational Site

São Paulo, 01246-000, Brazil

RECRUITING

GSK Investigational Site

Teresina, 64049-200, Brazil

RECRUITING

GSK Investigational Site

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

GSK Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

GSK Investigational Site

Helsinki, 00029, Finland

RECRUITING

GSK Investigational Site

Helsinki, 00180, Finland

RECRUITING

GSK Investigational Site

Kuopio, 70210, Finland

RECRUITING

GSK Investigational Site

Tampere, 33520, Finland

RECRUITING

GSK Investigational Site

Dijon, 21079, France

RECRUITING

GSK Investigational Site

Marseille, 13273, France

RECRUITING

GSK Investigational Site

Paris, 75010, France

RECRUITING

GSK Investigational Site

Paris, 75012, France

RECRUITING

GSK Investigational Site

Paris, 75015, France

RECRUITING

GSK Investigational Site

Poitiers, 86021, France

RECRUITING

GSK Investigational Site

Rennes, 35042, France

RECRUITING

GSK Investigational Site

Villejuif, 94805, France

RECRUITING

GSK Investigational Site

Bochum, 44791, Germany

RECRUITING

GSK Investigational Site

Düsseldorf, 40225, Germany

RECRUITING

GSK Investigational Site

Frankfurt, 60488, Germany

RECRUITING

GSK Investigational Site

Lübeck, 23562, Germany

RECRUITING

GSK Investigational Site

München, 81737, Germany

RECRUITING

GSK Investigational Site

Milan, 20133, Italy

RECRUITING

GSK Investigational Site

Milan, 20162, Italy

RECRUITING

GSK Investigational Site

Pisa, 56126, Italy

RECRUITING

GSK Investigational Site

Roma, 00168, Italy

RECRUITING

GSK Investigational Site

Aichi, 464-8681, Japan

RECRUITING

GSK Investigational Site

Chiba, 277-8577, Japan

RECRUITING

GSK Investigational Site

Hokkaido, 060-8648, Japan

RECRUITING

GSK Investigational Site

Osaka, 565-0871, Japan

RECRUITING

GSK Investigational Site

Tokyo, 104-0045, Japan

RECRUITING

GSK Investigational Site

Tokyo, 135-8550, Japan

RECRUITING

GSK Investigational Site

Tuxtla Gutiérrez, Chiapas, 29090, Mexico

RECRUITING

GSK Investigational Site

Cuernavaca, Morelos, 62448, Mexico

RECRUITING

GSK Investigational Site

Mexico City, 03100, Mexico

RECRUITING

GSK Investigational Site

Mexico City, 06100, Mexico

RECRUITING

GSK Investigational Site

San Pedro Garza García, 66260, Mexico

RECRUITING

GSK Investigational Site

Amsterdam, 1066 CX, Netherlands

RECRUITING

GSK Investigational Site

Maastricht, 6229 HX, Netherlands

RECRUITING

GSK Investigational Site

Rotterdam, 3015 GD, Netherlands

RECRUITING

GSK Investigational Site

Utrecht, 3584 CX, Netherlands

RECRUITING

GSK Investigational Site

Lrenskog, 1474, Norway

RECRUITING

GSK Investigational Site

Oslo, 0407, Norway

RECRUITING

GSK Investigational Site

Stavanger, 4011, Norway

RECRUITING

GSK Investigational Site

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

RECRUITING

GSK Investigational Site

Punta Pacifica Panama City Panama, Panama

RECRUITING

GSK Investigational Site

Brzozów, 36-200, Poland

RECRUITING

GSK Investigational Site

Koszalin, 75-581, Poland

RECRUITING

GSK Investigational Site

Warsaw, 02-034, Poland

RECRUITING

GSK Investigational Site

Seoul, Seoul Teugbyeolsi, 110 744, South Korea

RECRUITING

GSK Investigational Site

Seoul, 135-710, South Korea

RECRUITING

GSK Investigational Site

Seoul, 138-736, South Korea

RECRUITING

GSK Investigational Site

Barcelona, 08041, Spain

RECRUITING

GSK Investigational Site

HebrOn, 08035, Spain

RECRUITING

GSK Investigational Site

Madrid, 28007, Spain

RECRUITING

GSK Investigational Site

Madrid, 28034, Spain

RECRUITING

GSK Investigational Site

Madrid, 28041, Spain

RECRUITING

GSK Investigational Site

Pamplona, 31008, Spain

RECRUITING

GSK Investigational Site

Santander, 39011, Spain

RECRUITING

GSK Investigational Site

Zaragoza, 50009, Spain

RECRUITING

GSK Investigational Site

Gothenburg, SE-413 45, Sweden

RECRUITING

GSK Investigational Site

Lund, 22185, Sweden

RECRUITING

GSK Investigational Site

Stockholm, SE-118 83, Sweden

RECRUITING

GSK Investigational Site

Uppsala, 751 85, Sweden

RECRUITING

GSK Investigational Site

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): January 9, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (12); PL (3); ES (8); CA (4); JP (6); BR (3); IT (4); AU (2); NL (4); FR (8); NO (3); KR (3); SE (4); PA (2); DE (5); BE (4); FI (4); ME (5); GB (1)