A Phase 1b/2, Multicenter, Randomized, 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

Clinical Trial Details

This clinical trial is for adults who have been diagnosed with advanced or metastatic colorectal cancer (CRC) OR advanced or metastatic pancreatic cancer (PDAC).

The purpose of this study is to evaluate how well a new investigational drug called GSK5764227 works to treat advanced or metastatic colorectal cancer (CRC) or advanced or metastatic pancreatic cancer (PDAC), whether GSK5764227 is safe and well-tolerated, and how the body handles GSK5764227.
  
“Investigational” means that GSK5764227 has not yet been approved by the United States Food and Drug Administration (FDA). GSK5764227 is only given to people who participate in clinical studies. 
   
This study is a part of a bigger study for gastrointestinal cancers, which will include participants in separate groups (also called cohorts) depending on the type of gastrointestinal cancer they have.
   
In Part 1 Cohort A (advanced or metastatic colorectal cancer), participants will receive the study drug, GSK5764227, alone by infusion into a vein (blood vessel) either every 3 weeks (21 days) or every 2 weeks (14 days). In Part 1 Cohort A, study treatment will continue as long as the study doctor feels it is safe for participants to continue or until their disease gets worse. The study will take approximately 3 years to complete for these participants.
   
In Part 1 Cohort B (advanced or metastatic pancreatic cancer), participants will receive the study drug, GSK5764227, alone by infusion into a vein (blood vessel) every 3 weeks (21 days). In Part 1 Cohort B, study treatment will continue as long as the study doctor feels it is safe for participants to continue or until their disease gets worse. The study will take approximately 4 years to complete for these participants.

Key Eligibility: 
  1. Male or female aged 18 years or older.
  2. For Part 1 Cohort A, must have histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (CRC). Must have received at least 1 and no more than 2 lines of systemic treatment for advanced CRC, with documented progression on most recent prior line of therapy.
  3. For Part 1 Cohort B, must have histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (PDAC). Must have received 1 and no more than 1 line of therapy for advanced PDAC, with documented progression.

Detailed eligibility will be reviewed when participants contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Li Mow
(646) 962-3378
mem9233@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2507029124

ClinicalTrials.gov:

NCT06885034

Sponsor:

223675

Status

Open to Enrollment

Age Group

Adult

Sponsor