Recruiting

Phase 1

Phase 2

GSK5764227A 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

Code:

NCT06885034

Conditions

Gastrointestinal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Risvutatug Rezetecan

Drug 1

Drug 2

Drug 3

Drug 4

Study Details

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

Study ID

NCT06885034

Start date

Jun 11, 2025

Status verified date

Jul, 2026

Completion date

Jan 9, 2029

Anticipated

Primary completion date

Jan 10, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

451 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CRC-A: Risvutatug Rezetecan (Dose 1)

experimental: CRC-A: Risvutatug Rezetecan (Dose 2)

experimental: CRC-B: Risvutatug Rezetecan (Dose 3)

experimental: CRC-B: Risvutatug Rezetecan (Dose 4)

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

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

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

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

experimental: PDAC: Risvutatug Rezetecan (Dose 1)

Interventions

Risvutatug Rezetecan

Risvutatug Rezetecan will be administered

Drug 1

Drug 1 will be administered

Drug 2

Drug 2 will be administered

Drug 3

Drug 3 will be administered

Drug 4

Drug 4 will be administered

Primary outcome measure

Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 22 months ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

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

Locations

GSK Investigational Site

Recruiting

Los Alamitos, California, United States, 90505

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Vu Phan

GSK Investigational Site

Recruiting

Los Angeles, California, United States, 90089

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Heinz-Josef Lenz

GSK Investigational Site

Recruiting

Santa Monica, California, United States, 90404

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

J. Randolph Hecht

GSK Investigational Site

Recruiting

Whittier, California, United States, 90602

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Andrew Pham

GSK Investigational Site

Recruiting

Aurora, Colorado, United States, 80045

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Hannah Robinson

GSK Investigational Site

Recruiting

New York, New York, United States, 10021

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Rutika Mehta

GSK Investigational Site

Recruiting

New York, New York, United States, 10065

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Andrea Cercek

GSK Investigational Site

Recruiting

Durham, North Carolina, United States, 27710

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Nicholas Devito

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77479

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Kanwal Raghav

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Drew Rasco

GSK Investigational Site

Recruiting

Wenatchee, Washington, United States, 98801

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Lindsay Overton

GSK Investigational Site

Recruiting

Madison, Wisconsin, United States, 53792-0001

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Dustin Deming

GSK Investigational Site

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Richard Lee-Ying

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Eric Chen

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Francine Aubin

GSK Investigational Site

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Frederic Lemay

More Information

Sponsor

GlaxoSmithKline

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-08-03.