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Clinical Trials in the UK / NCT06885034
Recruiting Phase 1/2

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 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 1/2
Started
2025-06-11
Last updated
2026-08-03

Condition(s) studied

Gastrointestinal Neoplasms

Investigational drug(s) / intervention(s)

Risvutatug RezetecanDrug 1Drug 2Drug 3Drug 4

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)

Trial sites (85)

FacilityCityRegionStatus
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.

More GlaxoSmithKline trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT06885034 on ClinicalTrials.gov ↗ ← All trials in the UK