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A Study of GSK5764227 for Advanced Gastrointestinal Cancers

This study is testing a new treatment called GSK5764227, either by itself or with other treatments. We want to see how safe and effective it is, and how your body handles it. This study is for people aged 18 and older who have advanced gastrointestinal (digestive system) cancers that cannot be removed by surgery and who have already received other treatments. The main way we'll know if the treatment is working is by looking at how many participants have their cancer shrink or disappear (Objective Response Rate), which will be measured for up to about 22 months. The current status of this study is unclear, and it plans to enroll 451 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 451 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measure of success will be tracked for up to approximately 22 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06885034

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
GlaxoSmithKline
~451 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Risvutatug RezetecanDrug 1Drug 2Drug 3Drug 4

At a glance

Recruiting sites
85 of 85 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Confirmed Objective Response Rate (ORR)
Measured over Up to approximately 22 months

Conditions

Gastrointestinal Neoplasms

Explore related trials

Colorectal CarcinomaPancreatic CarcinomaSolid Neoplasm

Where it's being run

85 sites across 31 states
France8
Spain8
Japan6
Germany5
California4
Belgium4
Finland4
Italy4

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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).
Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification).
Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).
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

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.

What this trial measures

  • 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)