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A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201)

NCT06885034 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2026-08-03

No results posted yet for this study

Summary

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.

Conditions

  • Gastrointestinal Neoplasms

Interventions

BIOLOGICAL

Risvutatug Rezetecan

Risvutatug Rezetecan will be administered

DRUG

Drug 1

Drug 1 will be administered

DRUG

Drug 2

Drug 2 will be administered

DRUG

Drug 3

Drug 3 will be administered

DRUG

Drug 4

Drug 4 will be administered

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2028-01-10
Completion
2029-01-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Finland
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • Panama
  • Poland
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06885034 on ClinicalTrials.gov