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Phase 1/2 study to investigate the safety and preliminary efficacy of GSK5460025 alone or in combination with other anti-cancer agents in dMMR/MSI-H solid tumors
EU CTIS ID: 2025-522318-21-00
What this study is testing
"Part 1: Determine the safety and tolerability, and the recommended dose for expansion (RDE) and/or maximum tolerated dose (MTD) for GSK5460025 as monotherapy Part 2: Evaluate the preliminary anti-tumor activity of GSK5460025 as monotherapy in Colorectal cancer (CRC) and, separately, Endometrial cancer (EC) "
- Phase I and Phase II (Integrated)- First administration to humans
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
- Participant is at least 18 years of age.
- Part 2: Participant has histologically diagnosed advanced (unresectable, metastatic or recurrent) Colorectal cancer (CRC) or Endometrial cancer (EC).
- Part 2: Participant has received at least 1 but no more than 3 lines of systemic anticancer therapy for their advanced (unresectable, metastatic or recurrent) disease including at least one line of Immune checkpoint inhibitors (ICI) therapy.
- Part 2: Participant has measurable disease (i.e., at least 1 target lesion) during the Screening period per RECIST 1.1, as determined by the investigator.
- Participant has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor.
- Participant has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)/ Microsatellite Instability (MSI) status at the time of Pre-screening and MMR/MSI status will be determined by central reference laboratory.
You likely can't join if
- Participant has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced Adverse Events (AEs).
- Participant has received prior treatment with a Werner (WRN) inhibitor or Nucleotide Excision Repair Targeting (NERT) agent.
- Participant is unable to swallow and retain orally administered study treatment.
- Participant has untreated or progressed metastases in brain or CNS.
- Participant has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation by RECIST 1.1 criteria. Exceptions include basal or squamous cell carcinomas of the skin or in situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
- Participant has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs.
See the full eligibility criteria
- Participant is at least 18 years of age.
- Part 2: Participant has histologically diagnosed advanced (unresectable, metastatic or recurrent) Colorectal cancer (CRC) or Endometrial cancer (EC).
- Part 2: Participant has received at least 1 but no more than 3 lines of systemic anticancer therapy for their advanced (unresectable, metastatic or recurrent) disease including at least one line of Immune checkpoint inhibitors (ICI) therapy.
- Part 2: Participant has measurable disease (i.e., at least 1 target lesion) during the Screening period per RECIST 1.1, as determined by the investigator.
- Participant has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor.
- Participant has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)/ Microsatellite Instability (MSI) status at the time of Pre-screening and MMR/MSI status will be determined by central reference laboratory.
- Participant provides an archival or fresh (preferred) formalin fixed, paraffin embedded (FFPE) sample.
- Participant intends to receive GSK5460025 (as described in the protocol) as next treatment.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Participant is expected to have a minimum of 3 months life expectancy.
- Participant has adequate organ function, as defined in the protocol.
- Part 1: Participant has histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor and has exhausted all standard of care treatment options.
- Participant has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced Adverse Events (AEs).
- Participant has received prior treatment with a Werner (WRN) inhibitor or Nucleotide Excision Repair Targeting (NERT) agent.
- Participant is unable to swallow and retain orally administered study treatment.
- Participant has untreated or progressed metastases in brain or CNS.
- Participant has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation by RECIST 1.1 criteria. Exceptions include basal or squamous cell carcinomas of the skin or in situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
- Participant has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs.
- Participant has cirrhosis or current unstable liver or biliary disease.
- Participant has known hypersensitivity to any of the study interventions or any of their excipients.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan; Canada. 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.