Title
A Phase1b/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

Description
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

Objective
Primary-
Part 1A (CRC): CRC - A To evaluate the clinical efficacy of two Q3W doses of GSK5764227 in participants with advanced, unresectable CRC.
Part 1A (CRC): CRC-B - To evaluate the clinical efficacy of two Q2W doses of GSK5764227 in participants with advanced, unresectable CRC.
Part 1B (PDAC): To evaluate the clinical efficacy of GSK5764227 in participants with advanced, unresectable PDAC

Secondary
-To evaluate additional measures of clinical activity of GSK5764227 in participants with advanced, unresectable CRC/PDAC.
-To evaluate the safety and tolerability of GSK5764227 in participants with unresectable CRC/PDAC.
-To describe the exposure to GSK5764227 following IV infusion administration to participants with unresectable CRC/PDAC.
-To evaluate the immunogenicity of GSK5764227 in participants with unresectable CRC/PDAC.
-To evaluate participant reported AEs and tolerability.

Treatment 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.

Key Eligibility For full study eligibility see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Colon and Rectum

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital