Informations générales (source: ClinicalTrials.gov)
A Phase 1b/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
Interventional
Phase 1/Phase 2
GlaxoSmithKline (Voir sur ClinicalTrials)
juin 2025
juin 2028
02 décembre 2025
This study will check how well a new medicine, 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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Michel DUCREUX | 20/04/2026 11:40:06 | Contacter | ||
Critères
Tous
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).
- Must have received at least 1 and no more than 2 lines of systemic treatment for
advanced colorectal cancer (CRC), with documented progression on most recent prior
line of therapy.
- Must provide tumor tissue from a newly obtained fresh biopsy or an archival tumor
tissue.
PDAC Cohort
- Has histologically or cytologically confirmed unresectable, locally advanced or
metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).
- Must have received 1 and no more than 1 line of therapy for advanced PDAC, with
documented progression.
- Should provide tumor tissue at screening, where available or medically feasible.
All Cohorts
- Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
- 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 (CRC Cohort) or
first dose of study intervention (PDAC Cohort).
- Has any history of prior allogenic or autologous bone marrow transplant or other
solid organ transplant.
- Has known sensitivity to study intervention components or excipients or other
allergy that, in the opinion of the investigator or medical monitor, contraindicates
participation in the study.
- 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 serious infection within 4 weeks prior to the first dose.
- Known active infectious diseases requiring systemic treatment or known Human
immunodeficiency virus (HIV).
- Has serious arteriovenous thromboembolic events (such as deep vein thrombosis,
pulmonary embolism, etc.) within 3 months prior to the first dose.
- Has untreated brain or Central nervous system (CNS) metastases or brain/CNS
metastases that have progressed.
- Has current active pneumonitis or any history of pneumonitis requiring steroids or
immunomodulatory treatment within 90 days of planned [randomization] or any history
of drug-induced pneumonitis.
- Has a history of autoimmune disease that has required systemic treatments in the 2
years prior to screening.
- Has any active renal condition (e.g., infection, requirement for dialysis, or any
other significant renal condition that could affect the participant's safety).
- 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 any serious and/or unstable medical or psychiatric disorder or other
condition(s) (including laboratory assessment abnormalities) that could interfere
with the participant's safety, obtainment of informed consent, or compliance to the
study procedures.
- Has cirrhosis or current unstable liver or biliary disease per investigator
assessment defined by the presence of ascites, encephalopathy, coagulopathy,
hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
- Has documented presence of Hepatitis B surface antigen (HBsAg) or HBcAb at screening
or within 3 months prior to the first dose of study intervention.
- Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3
months prior to the first dose of study intervention.
- Has a positive HCV RNA test result at screening or within 3 months prior to the
first dose of study intervention.
- Has received immunosuppressive agents within 30 days prior to first dose of study
intervention (or requires long-term [30 days or longer]).
- Has received any prior therapy with an Antibody-drug conjugate (ADC) with a
Topoisomerase-1 (TOPO1)-inhibitor payload.
- Has received any live vaccine within 30 days of randomization (CRC Cohort) or before
first dose of study intervention (PDAC Cohort).
- Is currently enrolled or has participated in any other clinical study involving an
investigational study intervention or any other type of interventional medical
research and/or has received treatment with any anticancer or investigational agent
within 4 weeks prior to randomization.
- Is pregnant or breastfeeding.
- Is unable to adhere to the protocol defined SoA, including requirements for the
Follow-up Period of the study.