Study of S-531011 for Advanced Solid Tumors
This study is testing a new drug called S-531011, alone and in combination with other approved cancer medicines like pembrolizumab and bevacizumab, for people with advanced or metastatic (spread) solid tumors. You might be eligible if you have solid tumors that have returned or spread, and you have no standard treatment options, or you can't tolerate them. The study aims to find a safe dose of S-531011 and see how well these treatments shrink tumors. Researchers are also looking at specific genetic markers (biomarkers) like BRAF, EGFR, KRAS, and NRAS in your tumor. The study plans to enroll 282 participants.
- Study design
- This is an interventional study with an unclear phase, meaning it's testing a treatment. It plans to enroll 282 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured every 6 weeks for the first 24 weeks, then every 9 weeks until your disease progresses, for approximately 12 to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
At a glance
Conditions
Where it's being run
8 sites across 8 statesStudy leadership
- Shionogi Clinical Trials Administrator Clinical Support Help Line · STUDY_DIRECTOR · Shionogi
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Part A: Number of Participants with Treatment-emergent Adverse Events (TEAEs)Approximately 12 months (Part A-1); Approximately 24 months (Part A-2)
- Parts B, C, D, E: Objective Response RateEvery 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
- Parts B, C, D, E: Duration of ResponseEvery 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
- Parts B, C, D, E: Disease Control RateEvery 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
- Parts B, C, D, E: Time to ResponseEvery 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
- Parts B, C, D, E: Progression-free SurvivalEvery 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
- Parts B, C, D, E: Overall SurvivalEvery 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])