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Trial · NCT07902999

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryProgression-free survival (PFS)Up to 34 months
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the Blinded Independent Central Review or death due to any cause (whichever occurs first)
SecondaryProgression-free survival (PFS)Up to 34 months
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first)
SecondaryObjective Response Rate (ORR)Up to 34 months
ORR is defined as the proportion of subjects achieving the best overall response (BOR) as complete response (CR) or partial response (PR) according to RECIST 1.1 by investigator or Blinded Independent Central Review.
SecondaryDisease control rate (DCR)Up to 34 months
DCR defined as the number of patients were confirmed CR or PR or stable disease(SD) according to RECIST 1.1 by investigator or Blinded Independent Central Review divided by the patients with at least one tumour evaluation.
SecondaryDuration of response (DOR)Up to 34 months
DOR is defined as the time from the first record of CR or PR to the first record of disease progression as evaluated by investigators or Blinded Independent Central Review according to RECIST v1.1 or death.
SecondaryTime to Progression(TTP)Up to 34 monthsTTP is defined as the time from the time of randomization to the occurrence of disease progression according to Recist 1.1 by investigator or Blinded Independent Central Review.
SecondaryOverall Survival (OS)Up to 34 monthsOS is defined as the period from the start of randomization to the time of death due to any cause.
SecondarySafety AssessmentUp to 34 monthsThe incidence, severity and outcome of adverse events (AE), serious adverse events (SAE), immune-related adverse events (irAE) and adverse events of special interest (AESI) per NCI-CTCAE V6.0.
SecondaryCmaxUp to 34 monthsPeak Plasma Concentration
SecondaryAUCUp to 34 monthsArea under the plasma concentration versus time curve
SecondaryADA titerUp to 34 monthstiter of anti-drug antibody

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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