Tests risvutatug rezetecan in advanced gastrointestinal cancers after prior treatment

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.

ClinicalTrials.gov NCT06885034