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Trial · NCT07076095

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryFrequency of adverse events (AEs) and SAEs (Phase II)Approximately within 36 monthsTo investigate the safety characteristics.
SecondaryPharmacokinetic (PK) Cmax (Phase II)Approximately within 36 monthsPK parameters (Cmax) following single dose.
SecondaryPharmacokinetic (PK) Cmin (Phase II)Approximately within 36 monthsPK parameters (Cmin) following single dose.
SecondaryPharmacokinetic (PK) Tmax (Phase II)Approximately within 36 monthsPK parameters (Tmax) following single dose.
SecondaryPharmacokinetic (PK) AUC 0-t (Phase II)Approximately within 36 monthsPK parameters (AUC 0-t) following single dose.
SecondaryPharmacokinetic (PK) AUC 0-∞ (Phase II)Approximately within 36 monthsPK parameters (AUC 0-∞) following single dose.
SecondaryPharmacokinetic (PK) CL (Phase II)Approximately within 36 monthsPK parameters (CL) following single dose.
SecondaryPharmacokinetic (PK) Vd (Phase II)Approximately within 36 monthsPK parameters (Vd) following single dose.
SecondaryPharmacokinetic (PK) t1/2 (Phase II)Approximately within 36 monthsPK parameters (t1/2) following single dose.
SecondaryPharmacokinetic (PK) λz (Phase II)Approximately within 36 monthsPK parameters (λz) following single dose.
SecondaryPharmacokinetic (PK) Css,max (Phase II)Approximately within 36 monthsPK parameters (Css,max) following multiple dose.
SecondaryPharmacokinetic (PK) Css,min (Phase II)Approximately within 36 monthsPK parameters (Css,min) following multiple dose.
SecondaryPharmacokinetic (PK) Css,av (Phase II)Approximately within 36 monthsPK parameters (Css,av) following multiple dose.
SecondaryPharmacokinetic (PK) AUCss (Phase II)Approximately within 36 monthsPK parameters (AUCss) following multiple dose.
SecondaryPharmacokinetic (PK) CLss (Phase II)Approximately within 36 monthsPK parameters (CLss) following multiple dose.
SecondaryPharmacokinetic (PK) Vss (Phase II)Approximately within 36 monthsPK parameters (Vss) following multiple dose.
SecondaryPharmacokinetic (PK) R (Phase II)Approximately within 36 monthsPK parameters (R) following multiple dose.
SecondaryPharmacokinetic (PK) DF (Phase II)Approximately within 36 monthsPK parameters (DF) following multiple dose.
SecondaryIncidence of Anti-Drug Antibodies (ADA)(Phase II)Approximately within 36 months
SecondaryOverall survival (OS) (Phase II)Baseline through up to 2 years or until disease progressionOS as assessed using RECIST 1.1.

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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