Tests risvutatug rezetecan in advanced gastrointestinal cancers after prior treatment
Tests a new medicine, risvutatug rezetecan, in adults with advanced gastrointestinal cancer.
Plain-language title generated from the registry record
Registry 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)
Key facts
- Where
- Barcelona, Madrid, Pamplona, Santander, and Zaragoza, SpainSee the 5 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced colon, rectal or pancreatic cancer that cannot be removed by surgery. It tests a new medicine, Risvutatug rezetecan (GSK5764227).
- Age
- 18 years or older (or the legal age of consent where the study takes place).
- Sex
- All sexes can join.
- Disease stage
- Colon or rectal adenocarcinoma, or pancreatic adenocarcinoma, that is locally advanced or has spread and cannot be removed by surgery. The cancer must be confirmed under the microscope.
- Earlier treatment
- People must have had earlier treatment for the cancer. They cannot have had an antibody-drug conjugate with a Topoisomerase-1 (TOPO1)-inhibitor payload before.
Main reasons for not taking part
- Another cancer that got worse or needed treatment in the past 24 months
- Untreated or growing brain or central nervous system metastases
- Current or past interstitial lung disease or non-infectious pneumonitis needing high-dose steroids
- Past bone marrow or solid organ transplant
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Where in Spain
- BarcelonaBarcelona, SpainTaking people
- MadridMadrid, SpainTaking people
- PamplonaPamplona, SpainTaking people
- SantanderSantander, SpainTaking people
- ZaragozaZaragoza, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT06885034
- Record updated
- 19 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants are eligible to be included in the study only if all of the following criteria apply: All cohorts; Is at least 18 years of or the legal age of consent in the jurisdiction in which the study is taking place 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: 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 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 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; 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 severe, uncontrolled or active cardiovascular disorders; Has serious or poorly controlled hypertension; Participants are excluded from the study if any of the following criteria apply:; Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed; Is pregnant or breastfeeding.