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.
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).
Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification).
Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).
Is willing to use adequate contraception.
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.
Parallel
Risvutatug Rezetecan
Biological/VaccineRisvutatug Rezetecan will be administered
Drug 1
DrugDrug 1 will be administered
Drug 2
DrugDrug 2 will be administered
Drug 3
DrugDrug 3 will be administered
Drug 4
DrugDrug 4 will be administered
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Treatment groupsSee each treatment group below.
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)
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.
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.
Progression Free Survival (PFS)
PFS (assessed by investigator), defined as the time from date of randomization (for participants in CRC-A and CRC-B) or the date of first dose study intervention for participants in PDAC until the earliest date of documented disease progression per RECIST 1.1 or death due to any cause.
Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity
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