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Trial · NCT07901413

Registered outcomes27

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

ListOutcomeTime frameDescription
Primary
The type, severity (assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 [NCI-CTCAE V6.0]), relationship to the investigational product, and incidence rate of adverse event (AE) and serious advers
2 years
PrimaryThe type, severity (assessed according to NCI-CTCAE V6.0), and incidence rate of dose limiting toxicity (DLT)2 years
PrimarySingle-agent Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD)2 years
PrimaryParticipants with prostate cancer: Prostate-specific antigen (PSA50) response rate evaluated by Investigator according to Prostate Cancer Working Group 3 (PCWG3) criteria2 years
PrimaryParticipants with other tumor types: Investigator-assessed Objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 criteria2 years
PrimaryThe optimal dosing regimen for the subsequent study of ICP-B3812 years
SecondaryMaximum Concentration (Cmax)2 years
SecondaryTime to Maximum Plasma Concentration (Tmax)2 years
SecondaryHalf-life (T1/2)2 years
SecondaryArea Under the Serum or Plasma Concentration-Time Curve (AUC0-∞ and AUC0-t)2 years
SecondaryApparent Clearance Rate (CL/F)2 years
SecondaryTerminal Apparent Volume of Distribution (Vz/F)2 years
SecondarySteady-state Pharmacokinetic Parameters2 years
SecondaryORR2 years
SecondaryDisease Control Rate (DCR)2 years
SecondaryDuration of Response (DOR)2 years
Secondary
Participants with prostate cancer: radiographic progression-free survival (rPFS) evaluated by the Investigator according to RECIST V1.1 criteria (for soft tissue lesions) and PCWG3 criteria (for bone lesions)
2 years
SecondaryParticipants with prostate cancer: changes in serum PSA levels compared to baseline during the study: PSA50 response rate2 years
SecondaryParticipants with prostate cancer: PSA90 response rate2 years
SecondaryParticipants with prostate cancer:12-week PSA response rate2 years

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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