Comparing 9 approaches for gastrointestinal neoplasms
Official title: 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)
A Phase1 b/2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal Solid Tumors
- Phase 1
- 9 groups
- Sites in Calgary, Toronto and 2 more cities
- Recruiting
Interventions (5)
- Biological therapy
Risvutatug Rezetecan
Risvutatug Rezetecan will be administered
- Medication
Drug 1
Drug 1 will be administered
- Medication
Drug 2
Drug 2 will be administered
- Medication
Drug 3
Drug 3 will be administered
- Medication
Drug 4
Drug 4 will be administered
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
GSK Investigational Site
Calgary, Alberta
- Recruiting
GSK Investigational Site
Toronto, Ontario
- Recruiting
GSK Investigational Site
Montreal, Quebec
- Recruiting
GSK Investigational Site
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF).
- +CRC CohortCohortA group of participants sharing a characteristic, followed together.Read more →
- +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 capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocolProtocolThe detailed plan a study must follow.Read more →.
- +Has adequate organ function.
- +Has an ECOG performance status of 0 or 1.
- +Is willing to use adequate contraception.
Exclusion
- −Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
- −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 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 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 reactionAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →(s) from prior therapy that has(have) not recovered to Grade 1 or to the baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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.
- −Has had any major surgery within 28 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → or first dose of study intervention, depending on sub-cohortCohortA group of participants sharing a characteristic, followed together.Read more →/cohort assignment
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 9 groups in this study.
Groups A, B, C, D and I receive Risvutatug Rezetecan.
Registry label: A: CRC-A: Risvutatug Rezetecan (Dose 1) · B: CRC-A: Risvutatug Rezetecan (Dose 2) · C: CRC-B: Risvutatug Rezetecan (Dose 3) · D: CRC-B: Risvutatug Rezetecan (Dose 4) · I: PDAC: Risvutatug Rezetecan (Dose 1)
Group E receives Risvutatug Rezetecan and Drug 1.
Registry label: E: CRC-C: Risvutatug Rezetecan (Dose 3) + Drug 1
Group F receives Risvutatug Rezetecan, Drug 1, Drug 2 and Drug 3.
Registry label: F: CRC-D: Risvutatug Rezetecan (Dose 3) + Drug 1 + Drug 2 / Drug 3
Group G receives Risvutatug Rezetecan and Drug 4.
Registry label: G: CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4
Group H receives Risvutatug Rezetecan, Drug 4 and Drug 1.
Registry label: H: CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4 + Drug 1
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 451 people.
The study is currently expected to finish around January 2029.
The main measurement is taken over: Up to approximately 22 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Confirmed Objective Response Rate (ORR) — measured over Up to approximately 22 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06885034 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Risvutatug RezetecanBiological
Risvutatug Rezetecan will be administered
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Drug 1Drug
Drug 1 will be administered
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Drug 2Drug
Drug 2 will be administered
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Drug 3Drug
Drug 3 will be administered
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Drug 4Drug
Drug 4 will be administered
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 22 months.
The study as a whole is currently expected to finish around 2029-01-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 451 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Calgary, Alberta, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Sherbrooke, Quebec, Canada; New York, New York, United States; Wenatchee, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Wenatchee, Washington, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.