EMBOLD PanGI-201
Research type
Research Study
Full title
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.
IRAS ID
1013387
Contact name
Eleftheria Finger
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2025-520672-26
Clinicaltrials.gov Identifier
Research summary
This research study is being done to learn more about an investigational treatment, GSK5764227, in its treatment of patients with advanced gastrointestinal solid tumours.
GSK5764227 is a new class of drug, called an antibody-drug conjugate (ADC). It binds to a target called B7-H3, which is highly present on certain cancer cells, and then delivers a cancer-killing drug directly to those cells. This study will look at how the body reacts to the treatment, how the body handles the treatment, and how safe and effective this treatment is at different doses in participants with advanced colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC).
This is an open-label study. That means the study doctors and the participants will both be aware of the treatment given to the participants. The study consists of different parts. In Part 1, the study doctors will evaluate early signals of efficacy and safety; testing different doses and schedules.
Men and non-pregnant women can be included if they are aged 18 years or older and are diagnosed with advanced unresectable or metastatic CRC (who have received 1 or 2 prior treatments) or PDAC (who have received 1 prior treatment). Participants cannot be included if they have serious and unstable medical conditions related to other organs, such as uncontrolled heart problems, active lung inflammation, specific severe liver conditions, or untreated brain tumours, or if they have recently undergone major surgery.
Participants will receive GSK5764227 infusions into a vein, until disease progression, unacceptable side effects, withdrawal, or death. All participants will continue to receive safety follow-up until 90 days after last dose, and will be followed up every 8 weeks thereafter for survival status. The study is sponsored by GlaxoSmithKline (GSK).REC name
London - Chelsea Research Ethics Committee
REC reference
26/LO/0134
Date of REC Opinion
18 Mar 2026
REC opinion
Further Information Favourable Opinion