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Trial · NCT02937116

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants Experiencing Dose-limiting Toxicities (DLTs)Up to 28 days in Cycle 1
PrimaryNumber of All Study Participants Who Demonstrate a Tumor ResponseThrough out the study (up to 2 years)
PrimaryObjective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by InvestigatorThrough out the study (up to 2 years)ORR was defined as the percentage of participants in the analysis population who had achieved BOR of CR or PR according to RECIST 1.1.
SecondaryPFS According to RECIST 1.1 as Assessed by InvestigatorThrough out the study (up to 2 years)
SecondaryDOR According to RECIST 1.1 as Assessed by InvestigatorThrough out the study (up to 2 years)
SecondaryTTR According to RECIST 1.1 as Assessed by InvestigatorThrough out the study (up to 2 years)
SecondaryOS for ParticipantsThrough out the study
SecondaryArea Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29
SecondaryMaximum Concentration (Cmax) of Sintilimab in Solid Tumor ParticipantsCycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
SecondaryTime to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor ParticipantsCycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
SecondaryThe Half-life (t1/2) of IBI308 in Plasma After Single Dose AdministrationCycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
SecondaryVolume of Distribution of IBI308 in Plasma After Single Dose AdministrationCycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
SecondaryClearance of IBI308 in Plasma After Single Dose AdministrationCycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

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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