Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
GlaxoSmithKline (Voir sur ClinicalTrials)
juin 2025
janvier 2029
05 août 2026
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.
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).
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.