A Phase 1/2 interventional study of Risvutatug Rezetecan in Gastrointestinal Neoplasms, sponsored by GlaxoSmithKline. Recruiting at 85 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Treatment
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.
695 studies on the registry are indexed under Gastrointestinal Neoplasms; 209 are open to participants now.
This study's planned enrollment of 346 is above the median of 74 across 494 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 19, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply: All cohorts
PDAC Cohort
All Cohorts
Exclusion criteria:
Participants are excluded from the study if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Risvutatug Rezetecan
Biological: Risvutatug Rezetecan
Biological: Risvutatug Rezetecan
Biological: Risvutatug Rezetecan
Biological: Risvutatug Rezetecan
Biological: Risvutatug Rezetecan
Risvutatug Rezetecan will be administered
Confirmed Objective Response Rate (ORR)
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)
Time frame: Up to approximately 22 months
Unconfirmed ORR
Unconfirmed ORR is defined as the proportion of participants who have achieved a BOR of CR or PR as assessed by investigator, according to RECIST 1.1.
Time frame: Up to approximately 37 months
Duration of Response (DoR)
DoR is defined as the time from the date of the first documented objective response (CR/PR as assessed by investigator according to RECIST 1.1) until the date of the first documented progressive disease (PD) or death, whichever is earlier.
Time frame: Up to approximately 37 months
Progression Free Survival (PFS)
PFS (assessed by investigator), defined as the time from date of randomization (CRC) or the date of first dose of study intervention (PDAC) until the earliest date of documented disease progression per RECIST 1.1 or death due to any cause.
Time frame: Up to approximately 37 months
Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity
Time frame: Up to approximately 37 months
Number of participants with AEs leading to dose modifications, discontinuation of study interventions or death
Time frame: Up to approximately 37 months
Changes from baseline in vital signs: Temperature (degree Celsius)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline vital signs: Respiratory rate (breaths per minute)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline vital signs: Pulse rate (beats per minute)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline vital signs: Blood pressure [millimetres of mercury (mmHg)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline in hematology parameters: [White blood cell count (WBCs per microliter)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline in hematology parameters: [Haemoglobin (Hgb) (grams per deciliter)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline in hematology parameters:[Haematocrit (Proportion of red blood cells in blood)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from Baseline haematology parameter: [Red Blood Cell Count (RBC) (million cells per microliter)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from Baseline haematology parameter: Platelet count (cells per microliter)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical chemistry parameters: Total Protein, Albumin (Grams per deciliter)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical Chemistry parameters: Total Bilirubin and Direct Bilirubin, Glucose, Calcium, Potassium, Sodium, Magnesium, Urea Nitrogen or urea, and Creatinine (milligrams per deciliter)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical Chemistry parameters: Lactate dehydrogenase, Amylase and Lipase (units per liter)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical Chemistry parameters: Chloride (millimoles per liter)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline Clinical Chemistry parameters: Creatinine clearance (milliliters per minute)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline cardiac function: Electrocardiogram (ECG) (milliseconds)
Time frame: Baseline (Day 1) and up to approximately 37 months
Changes from baseline Eastern Cooperative Oncology Group performance status (ECOG-PS)
Time frame: Baseline (Day 1) and up to approximately 37 months
Maximum observed concentration (Cmax) of Risvutatug Rezetecan (conjugated antibody)and GSK5757810 (small molecule toxin)
Time frame: Up to approximately 37 months
Time to reach Cmax (Tmax) of Risvutatug Rezetecan (conjugated antibody) and GSK5757810 (small molecule toxin)
Time frame: Up to approximately 37 months
Area under the concentration-time curve (AUC) of Risvutatug Rezetecan (conjugated antibody) and GSK5757810 (small molecule toxin)
Time frame: Up to approximately 37 months
Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)
Time frame: Up to approximately 37 months
Titers of ADA against GSK5764227
Time frame: Up to approximately 37 months
Number of participants with symptomatic AEs, by severity, as measured by Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes a library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE
Time frame: Up to approximately 37 months
Level of bother of AEs as measured by Functional Assessment of Cancer Therapy - Item GP5 (FACT-GP5)
The FACT-GP5 item is a single item from the FACT-G that assesses how bothersome the side effects of treatment are for cancer patients. The item has a 5-category response scale ranging from 0 to 4. Higher scores indicate a higher degree of AE bother.
Time frame: Up to approximately 37 months
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk-studyregister.com
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jan 2029, 42 months after the start.
Of 36 phase 1/2 interventional studies under Gastrointestinal Neoplasms, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 42. This study's planned 42 months is below that.
Primary completion moved once since we started tracking on Sep 25, 2026: Jan 2028 → Jan 2029, on Oct 19, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Risvutatug rezetecan