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Trial · NCT07235202

Registered outcomes17

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

ListOutcomeTime frameDescription
PrimaryNumber of participants who experience one or more dose-limiting toxicities (DLTs)Approximately 12 months
PrimaryMaximum Tolerated Dose (MTD) of MR001Approximately 12 monthsThe maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
PrimaryIncidence of Adverse Events (AEs) as Assessed by CTCAE v5.0Approximately 30 months
PrimaryObjective Response Rate (ORR)Approximately 24 months
PrimaryBest Overall Response (BOR)Approximately 24 months
PrimaryDisease control rate (DCR)Approximately 24 months
SecondaryRecommended Phase II Dose (RP2D) of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)Approximately 12 months
SecondaryProgressionfree survival (PFS)Approximately 24 months
SecondaryOverall survival (OS)Approximately 30 months
SecondaryArea Under the Plasma ConcentrationTime Curve (AUC) of MR001Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
SecondaryMaximum Plasma Concentration (Cmax) of MR001Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
SecondaryHalf-life (T1/2) of MR001Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
SecondaryIncidence of Antidrug Antibodies (ADA) to MR001Predose in every 4 cycles for approximately 18 months (each cycle = 2 weeks or 4 weeks)
SecondaryChange from baseline at different time points for Th1 in plasmaPredose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
SecondaryChange from baseline at different timepoints for Th2 in plasmaPredose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
SecondaryChange from baseline at different timepoints for TGF-β1 in plasmaPredose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
SecondaryChange from baseline at different time points for CD4 in plasmaPredose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

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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