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Trial · NCT03320330

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Dose Limiting ToxicitiesUp to 28 daysThe patients who had DLT in dose escalation course.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPatients Who Had Grade 3 or Above Toxicities With the Three Attributions, 'DEFINITE', 'POSSIBLE','PROBABLE'Up to 28 daysPart A and B PatientsParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYHalf-life
Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
all toxicity evaluable patientshoursMEAN
PRIMARYTime to Maximum Concentration (T Max)
Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
All toxicity evaluable patientshoursMEAN
PRIMARYMaximum Concentration (C Max)
Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
All toxicity evaluable patientsug/mlMEAN
PRIMARYArea Under Curve (AUC)
Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
All toxicity evaluable patientshr*ug/mlMEAN
PRIMARYClearance
Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
All toxicity evaluable patientsml/hrMEAN
PRIMARYDisease Control Rate (Part A)Up to 4 monthsparticipantsNUMBER
PRIMARYResponse (Complete Response or Partial Response) (Part B)Up to 168 daysparticipantsNUMBER
SECONDARYT-lymphocyte SaturationUp to 28 daysAll Eligible Patientspercent of T-lymphocyte SaturationMEAN
SECONDARYTotal Soluble SEMA4DUp to 28 daysAll eligible patientspg/mLMEAN
SECONDARYImmunogenicity of PepinemabUp to 3 years
The planned assays for ADA were unable to generate interpretable results due to limitations of the assay which resulted in higher levels of false positive results. These samples were re-run and only one confirmed positive result out of 81 samples, which was considered to be a true positive ADA. Even this one confirmed positive result had a negative titer, which further signifies a possible false positive or very low-level ADA. Therefore, results were determined to be unreliable and invalid.

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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