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NCT05091528 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events

A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers · Source last updated 2022-08-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
0 weeks

What was measured

Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose expansion cohorts.

Analysis population: No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor.

Groups in this outcome

SBT6050 + T-DXd (6.4 mg/kg)

SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles

SBT6050 + Tucatinib + Trastuzumab

SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
SBT6050 + T-DXd (6.4 mg/kg)0
SBT6050 + Tucatinib + Trastuzumab0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose expansion cohorts.
groups
  1. description
    SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
    id
    OG000
    title
    SBT6050 + T-DXd (6.4 mg/kg)
  2. description
    SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
    id
    OG001
    title
    SBT6050 + Tucatinib + Trastuzumab
population Description
No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor.
reporting Status
POSTED
time Frame
0 weeks
title
Number of Participants With Treatment-emergent Adverse Events
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice