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Trial · NCT07595237

Registered outcomes21

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

ListOutcomeTime frameDescription
PrimaryDose-limiting toxicity(DLT) of the single dose4 to 6weeksOccurance of DLT in the first cycle of each group
PrimaryThe safety and tolerance of 177Lu-DOTA-SNA0404 to 6 weeksThe occurance and stage of AE and SAE according to CTCAE
PrimaryThe safety and tolerance of 177Lu-DOTA-SNA0404 to 6 weeksThe rates of abnormal laborotary tests after administration
PrimaryThe safety and tolerance of 177Lu-DOTA-SNA0404 to 6 weeksThe rates of abnormal vital signs after administration
PrimaryThe safety and tolerance of 177Lu-DOTA-SNA0404 to 6 weeksThe rates of abnormal physical examination after administration
PrimaryThe safety and tolerance of 177Lu-DOTA-SNA0404 to 6 weeksThe rates of abnormal 12-lead ECG after administration
SecondaryThe biodistribution of SNA0401 weekAbsorbed dose in major organs throughout the body (red bone marrow, kidneys, liver, intestines, etc.)
SecondaryThe tumor uptake of SNA0401 weekSUVmax and SUVmean of tumor
SecondaryThe tumor uptake of SNA0401 weekThe retention time of tumor
SecondaryThe tumor uptake of SNA0401 weekThe ID% of tumor
SecondaryTo evaluate the radiological characteristics 177Lu-DOTA-SNA0401 weekRradiation doses in whole blood, serum, urine measured using a gamma counter
SecondaryThe pharmacokinetic of the SNA040 protein1 weekPeak plasma concentration (Cmax) of the SNA040
SecondaryThe pharmacokinetic of the SNA040 protein1 weekArea under the concentration-time curve (AUC) of the SNA040
SecondaryThe pharmacokinetic of the SNA040 protein1 weekClearance (CL) of the SNA040
SecondaryAssessment of the immunogenicity of SNA0401 weekOccurance of positive immunogenicity test
SecondaryAssessing tumour response according to RECIST1.14 to 6 weeksThe DCR of tumors
SecondaryAssessing tumour response according to RECIST1.14 to 6 weeksThe ORR of tumors
SecondaryAssessing tumour response according to RECIST1.14 to 6 weeksThe DOR of tumors
SecondaryExplore the PFS of subjects2 yearsPFS according to the RECIST1.1
SecondaryExplore the OS of subjects2 yearsOverall survival (OS) according to the RECIST1.1

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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