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)
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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Confirmed Objective Response Rate (ORR) — Up to approximately 22 months 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)
Trial sites (85)
Facility
City
Region
Status
GSK Investigational Site
Los Alamitos
California
Recruiting
GSK Investigational Site
Los Angeles
California
Recruiting
GSK Investigational Site
Santa Monica
California
Recruiting
GSK Investigational Site
Whittier
California
Recruiting
GSK Investigational Site
Aurora
Colorado
Recruiting
GSK Investigational Site
New York
New York
Recruiting
GSK Investigational Site
New York
New York
Recruiting
GSK Investigational Site
Durham
North Carolina
Recruiting
GSK Investigational Site
Houston
Texas
Recruiting
GSK Investigational Site
San Antonio
Texas
Recruiting
GSK Investigational Site
Wenatchee
Washington
Recruiting
GSK Investigational Site
Madison
Wisconsin
Recruiting
GSK Investigational Site
Heidelberg
Victoria
Recruiting
GSK Investigational Site
Melbourne
Victoria
Recruiting
GSK Investigational Site
Bonheiden
Belgium
Recruiting
GSK Investigational Site
Brussels
Belgium
Recruiting
GSK Investigational Site
Leuven
Belgium
Recruiting
GSK Investigational Site
Roeselare
Belgium
Recruiting
GSK Investigational Site
Porto Alegre
Brazil
Recruiting
GSK Investigational Site
São Paulo
Brazil
Recruiting
GSK Investigational Site
Teresina
Brazil
Recruiting
GSK Investigational Site
Calgary
Alberta
Recruiting
GSK Investigational Site
Toronto
Ontario
Recruiting
GSK Investigational Site
Montreal
Quebec
Recruiting
GSK Investigational Site
Sherbrooke
Quebec
Recruiting
GSK Investigational Site
Helsinki
Finland
Recruiting
GSK Investigational Site
Helsinki
Finland
Recruiting
GSK Investigational Site
Kuopio
Finland
Recruiting
GSK Investigational Site
Tampere
Finland
Recruiting
GSK Investigational Site
Dijon
France
Recruiting
GSK Investigational Site
Marseille
France
Recruiting
GSK Investigational Site
Paris
France
Recruiting
GSK Investigational Site
Paris
France
Recruiting
GSK Investigational Site
Paris
France
Recruiting
GSK Investigational Site
Poitiers
France
Recruiting
GSK Investigational Site
Rennes
France
Recruiting
GSK Investigational Site
Villejuif
France
Recruiting
GSK Investigational Site
Bochum
Germany
Recruiting
GSK Investigational Site
Düsseldorf
Germany
Recruiting
GSK Investigational Site
Frankfurt
Germany
Recruiting
+ 45 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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