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Trial · NCT05672316

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryRecommended phase 2 dose of botensilimab, balstilimab, and regorafenib (Phase I)Cycle 1 (6 weeks)Will conduct a Simon 2-stage optimal design study.
PrimaryIncidence of dose limiting toxicities (DLT) (Phase I)Cycle 1 (6 weeks)Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
PrimaryOverall response rate (ORR) (Phase II)Up to 2 yearsAssessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
SecondaryIncidence of DLTs (Phase I)Up to 2 yearsGraded according to the NCI CTCAE v.5.0.
SecondaryORR (Phase I)Up to 2 yearsAssessed by RECIST 1.1.
SecondaryProgression-free survival (PFS) (Phase I)Time to disease progression/ relapse or death as a result of any cause, assessed up to 2 years
SecondaryOverall survival (OS) (Phase I)Time to death as a result of any cause, assessed up to 2 years
SecondaryPFS (Phase II)Time to disease progression or death as a result of any cause, assessed up to 2 years
SecondaryOS (Phase II)Time to death as a result of any cause, assessed up to 2 years
SecondaryDuration of response (Phase II)Time to progression or death, starting at the time when a response is experienced, assessed up to 2 years
SecondaryIncidence of toxicity (Phase II)Up to 2 yearsGraded according to the NCI CTCAE v.5.0.

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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