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Trial · NCT07909031

Registered outcomes22

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

ListOutcomeTime frameDescription
PrimaryPart 1: Dose Escalation - incidence and nature of dose-limiting toxicitiesFrom the first dose of study drug up until approximately 1 monthPer cohort
PrimaryPart 1: Dose Escalation - characterization of the maximum tolerated dose, if applicableFrom the first dose of study drug up until approximately 1 monthPer cohort
PrimaryAll Parts - incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse eventsFrom the first dose of study drug until 90 days after the last dose of study drugEvents are graded according to National Cancer Institute Cancer Terminology Criteria for Adverse Events (NCI CTCAE)
PrimaryAll Parts - incidence and severity of TEAEs leading to dose modificationsFrom the first dose of study drug until 90 days after the last dose of study drug
PrimaryAll Parts - incidence and severity of TEAEs leading to treatment discontinuationFrom the first dose of study drug until 90 days after the last dose of study drug
SecondaryAll Parts - determination of recommended phase 2 dose(s)From the first dose of study drug until 90 days after the last dose of study drug
SecondaryAll Parts - serum CR-002 pharmacokinetic parametersPredose until up to approximately 36 monthsAUC0-inf after a single dose and steady state parameters, as appropriate
SecondaryAll Parts - serum CR-002 pharmacokinetic parametersPredose until up to approximately 36 monthsAUClast after a single dose and steady state parameters, as appropriate
SecondaryAll Parts - serum CR-002 pharmacokinetic parametersPredose until up to approximately 36 monthsCmax after a single dose and steady state parameters, as appropriate
SecondaryAll Parts - serum CR-002 pharmacokinetic parametersPredose until up to approximately 36 monthsTmax after a single dose and steady state parameters, as appropriate
SecondaryAll Parts - serum CR-002 pharmacokinetic parametersPredose until up to approximately 36 monthsVd after a single dose and steady state parameters, as appropriate
SecondaryAll Parts - serum CR-002 pharmacokinetic parametersPredose until up to approximately 36 monthsCL after a single dose and steady state parameters, as appropriate
SecondaryAll Parts - serum CR-002 pharmacokinetic parametersPredose until up to approximately 36 monthst½ after a single dose and steady state parameters, as appropriate
SecondaryAll Parts - incidence of participants with detectable antidrug antibodiesPredose until up to approximately 36 months
SecondaryAll Parts - overall response rate (ORR)Predose until up to approximately 36 months
SecondaryAll Parts - duration of response (DOR)Predose until up to approximately 36 months
SecondaryAll Parts - disease control rate (DCR)Predose until up to approximately 36 months
SecondaryAll Parts - clinical benefit rate (CBR)Predose until up to approximately 36 months
SecondaryAll Parts - time to response (TTR)Predose until up to approximately 36 months
SecondaryAll Parts - progression free survival (PFS)Predose until up to approximately 36 months

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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