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Trial · NCT07894874

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe occurrence and frequency of Treatment-emergent adverse events (TEAEs)From first dose through 30 days after the last dose of study treatment(up to approximately 36 months)phase 1a
PrimaryThe occurrence and frequency of Dose-limiting toxicities (DLTs) DLTs during the studyfirst cycle (each cycle is 21 days)phase 1a
PrimaryObjective remission rate (ORR) assessed by the investigator according to RECIST v1.1Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)Phase 1b
SecondaryObjective Response Rate (ORR) per RECIST v1.1Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)Phase 1a
SecondaryDisease Control Rate (DCR) per RECIST v1.1Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)Phase 1a and Phase 1b
SecondaryProgression-Free Survival (PFS) per RECIST v1.1Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)Phase 1a and Phase 1b
SecondaryDuration of Response (DOR) per RECIST v1.1Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)Phase 1a and Phase 1b
SecondaryOverall Survival (OS)approximately 36 monthsDuration from the date of initial treatment to the date of death due to any cause
SecondaryArea Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Time Point (AUC₀-t)every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)Area under the plasma concentration-time curve of YF550 from time zero to the last measurable time point.
SecondaryArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC₀-∞)every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)Area under the plasma concentration-time curve of YF550 from time zero extrapolated to infinity.
SecondaryMean Residence Time (MRT)every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)Mean residence time of YF550 in plasma.
SecondaryMaximum Observed Plasma Concentration (Cmax)every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)Maximum observed plasma concentration of YF550.
SecondaryTime to Maximum Observed Plasma Concentration (Tmax)every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)Time to reach the maximum observed plasma concentration of YF550.
SecondaryTerminal Elimination Half-Life (t½)every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)Terminal elimination half-life of YF550 in plasma.
SecondaryApparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F)every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)Apparent volume of distribution of YF550 during the terminal phase following extravascular administration.
SecondaryApparent Total Clearance Following Extravascular Administration (CL/F)every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)Apparent total clearance of YF550 following extravascular administration.
SecondaryChange from Baseline in QT/QTc IntervalUp to 16 days after dosingPhase 1a

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license 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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