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Evaluation of efficacy and safety of GSK5764227 (alone and in combination) in participants with previously treated advanced unresectable or metastatic gastrointestinal solid tumors
EU CTIS ID: 2025-520672-26-00
What this study is testing
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
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All cohorts: Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the ICF
- Has adequate organ function as defined in the protocol
- Cohort A (CRC) Part 1A Participants only: Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by WHO classification).
- Cohort A (CRC) Part 1A Participants only: Must have received 1-2 lines of systemic treatment for advanced CRC including the following: a fluoropyrimidine, oxaliplatin and/or irinotecan, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody, if the approved biologic therapy(ies) is available.
- Cohort A (CRC) Part 1A Participants only: Must provide tumor tissue from a newly obtained fresh biopsy or an archival tumor tissue.
- Cohort B (PDAC) Part 1B Participants only: Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).
You likely can't join if
- Has had any major surgery within 28 days prior to randomization (CRC-A and CRC-B) or before first dose of study intervention (Cohort B)
- 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 CNS metastases or brain/CNS metastases that have progressed.
- Principal Exclusion Criteria Has current active pneumonitis or any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned randomization (CRC-A and CRC-B) or planned first dose of study intervention (Cohort B) or any history of drug-induced pneumonitis.
See the full eligibility criteria
- All cohorts: Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the ICF
- Has adequate organ function as defined in the protocol
- Cohort A (CRC) Part 1A Participants only: Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by WHO classification).
- Cohort A (CRC) Part 1A Participants only: Must have received 1-2 lines of systemic treatment for advanced CRC including the following: a fluoropyrimidine, oxaliplatin and/or irinotecan, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody, if the approved biologic therapy(ies) is available.
- Cohort A (CRC) Part 1A Participants only: Must provide tumor tissue from a newly obtained fresh biopsy or an archival tumor tissue.
- Cohort B (PDAC) Part 1B Participants only: Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).
- Cohort B (PDAC) Part 1B Participants only: Must have received 1 and no more than 1 line of therapy for advanced PDAC, with documented progression.
- Cohort B (PDAC) Part 1B Participants only: Should provide tumor tissue at screening, where available or medically feasible.
- All cohorts: Has at least 1 target lesion per RECIST 1.1
- Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before randomization (CRC-A and CRC-B) or before first dose of study intervention (Cohort B)
- Has had any major surgery within 28 days prior to randomization (CRC-A and CRC-B) or before first dose of study intervention (Cohort B)
- 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 CNS metastases or brain/CNS metastases that have progressed.
- Principal Exclusion Criteria Has current active pneumonitis or any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned randomization (CRC-A and CRC-B) or planned first dose of study intervention (Cohort B) or any history of drug-induced pneumonitis.
- 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 ADC with a TOPO1-inhibitor payload
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
- Brazil
- Australia
- Japan
- Canada
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of; Brazil; Australia; Japan; Canada and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.