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Trial · NCT05323656

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYBest Percentage Change in Tumour SizeBaseline to at least 15 weeks and up to 51 weeksFull Analysis SetPercentage change from baselineLEAST_SQUARES_MEAN
SECONDARYProgression Free Survival (PFS)Baseline up to approximately 21 monthsFull Analysis SetdaysMEDIAN
SECONDARYChange From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour TissueBaseline up to approximately 9 weeksFull Analysis Set% positivity of tumour stromal componentMEAN
SECONDARYChange From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour TissueBaseline up to approximately 9 weeksFull Analysis Set)cells/High Power Field (HPF)MEAN
SECONDARYChange From Baseline in the Number of Regulatory T-cells in Tumour TissueBaseline up to approximately 9 weekscells/High Power Field (HPF)MEAN
SECONDARYOverall Response Rate (ORR)Baseline up to approximately 12 monthsFull Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDuration of Response (DoR)Baseline up to approximately 12 monthsFull Analysis SetdaysNUMBER
SECONDARYDisease Control Rate (DCR)Baseline up to approximately 12 monthsFull Analysis Setpercentage of participantsNUMBER
SECONDARYOverall Survival (OS)Baseline up to 12 monthsFull Analysis Setpercentage of participantsNUMBER
SECONDARYNumber of Participants With Adverse Events (AEs)Baseline up to approximately 21 monthsSafety Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Adverse Events of Special Interest (AESI)Baseline up to approximately 21 monthsSafety Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYLevels of Programmed Death-ligand 1 (PD-L1) Expression in Tumour TissueBaseline up to approximately 9 weeksFull Analysis SetratioMEAN
SECONDARYChange From Baseline in CAFs Cell Type Abundance Based on Gene Expression ProfilesBaseline up to approximately 9 weeksFull Analysis Set with paired observationsCIBERSORTx Absolute Abundance ratioMEAN
SECONDARYChange From Baseline in CD8+ TILs Cell Type Abundance Based on Gene Expression ProfilesBaseline up to approximately 9 weeksFull Analysis Set with paired observationsCIBERSORTx Absolute Abundance ratioMEAN
SECONDARYChange From Baseline in Regulatory T-cell Abundance Based on Gene Expression ProfilesBaseline up to approximately 9 weeksFull Analysis Set with paired observationsCIBERSORTx Absolute Abundance ratioMEAN
SECONDARYArea Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC[0-24]-ss) of SetanaxibBaseline, Week 3, week 9, week 24, week 51PK analysis setug*h*mL-¹GEOMETRIC_MEAN
SECONDARYArea Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC24-ss) of GKT138184Baseline, Week 3, week 9, week 24, week 51PK analysis setug*h*mL-¹GEOMETRIC_MEAN
SECONDARYMinimum Plasma Concentration at Steady State (Cmax-ss) of SetanaxibBaseline, Week 3, week 9, week 24, week 51PK analysis setug*mL-¹GEOMETRIC_MEAN
SECONDARYMinimum Plasma Concentration at Steady State (Cmin-ss) of GKT138184Baseline, Week 3, week 9, week 24, week 51PK analysis setug*mL-¹GEOMETRIC_MEAN
SECONDARYMaximum Plasma Concentration at Steady State (Cmax-ss) of SetanaxibBaseline, Week 3, week 9, week 24, week 51PK analysis setug*mL-¹GEOMETRIC_MEAN

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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