Risvutatug rezetecan for Advanced Gastrointestinal Cancer
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
Phase 1Phase 2Interventional Study
Gastrointestinal Neoplasms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
451 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for
This trial is looking for adults with advanced gastrointestinal cancer that cannot be surgically removed. Participants will take a new medicine and be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have advanced gastrointestinal cancer that cannot be surgically removed.
I am willing to use contraception.
I can provide signed consent for the study.
I have an ECOG performance status of 0 or 1.
I have adequate organ function.
You may not be able to join if
I have had another cancer that required treatment in the past 24 months.
I have had major surgery in the past 28 days.
I have a history of bone marrow or solid organ transplant.
I have severe or uncontrolled heart problems.
I have serious high blood pressure.
I have had significant bleeding problems in the past month.
I have untreated or worsening brain or central nervous system metastases.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
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 Cohor…
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.
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