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Trial · NCT07009457

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimarySHR-1316 serum trough concentration (Ctrough)Day1 pre-dose to Day28.
PrimaryArea under the concentration curve from time 0 to 21 days for SHR-1316 (sc) (AUC0-21d)Day1 pre-dose to Day21.
PrimaryArea under the concentration curve from time 0 to 28 days for SHR-1316 (sc) (AUC0-28d)Day1 pre-dose to Day28.
SecondaryMaximum Concentration of SHR-1316 (sc) (Cmax)Day1 pre-dose to Day28.
SecondaryTime to maximum plasma concentration (Tmax)Day1 pre-dose to Day28.
SecondaryTerminal half-life (t1/2)Day1 pre-dose to Day28.
SecondaryIncidence and severity of adverse events (AEs)About 2 years.
SecondaryObjective Response Rate (ORR)About 2 years.
SecondaryDuration of Relief (DoR)About 1.5 years.
SecondaryDisease Control Rate (DCR)About 2 years.
SecondaryProgression-free Survival (PFS)About 2 years.
SecondaryOverall Survival (OS)About 3 years.

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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