GSK5764227 for adults with advanced unresectable gastrointestinal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 study gives GSK5764227 alone or in combination to adults with unresectable or metastatic gastrointestinal cancers to measure safety, side effects, pharmacokinetics, and early signs of tumor response. The trial includes separate cohorts for colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC), with CRC patients having received 1–2 prior lines of systemic therapy and PDAC patients having received one prior systemic therapy. Participants must provide tumor tissue (fresh biopsy or archival) and will undergo regular imaging and laboratory monitoring to track response and how the drug is handled by the body. The study is conducted at selected GSK investigational sites and follows the typical early-phase dose-finding and expansion approach.

Why it matters

Who can join: the full rules

Inclusion criteria:

Participants are eligible to be included in the study only if all of the following criteria apply: All cohorts

* Is at least 18 years of or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent form (ICF). CRC Cohort
* Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification).

PDAC Cohort

* Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).

All Cohorts

* Is willing to use adequate contraception.
* Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
* Has an ECOG performance status of 0 or 1.
* Has adequate organ function.

Exclusion criteria:

Participants are excluded from the study if any of the following criteria apply:

* 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.
* Has serious or poorly controlled hypertension.
* Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
* Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
* Has evidence of current ILD/non-infectious pneumonitis or a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids Or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging.
* Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy.
* Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload.
* Is pregnant or breastfeeding.

Where it's running

• GSK Investigational Site
  Los Alamitos, California, United States Recruiting
• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  Santa Monica, California, United States Recruiting
• GSK Investigational Site
  Whittier, California, United States Recruiting
• GSK Investigational Site
  Aurora, Colorado, United States Recruiting
• GSK Investigational Site
  New York, New York, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.