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ado-trastuzumab emtansine

Phase 2

Solid Tumor Cancers | Small molecule | Other |Roche Holding AG|Last Updated: Sep 9, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment131

FDA Designations

No designations recorded

Clinical trial landscape

ado-trastuzumab emtansine · 1 trial · 4 indications

Phase 2 1
NCT02675829Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant CancersSolid Tumor Cancers
COMPLETED131 Analytics
PHASE2COMPLETED
Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers
Solid Tumor CancersUnlock trial analytics

Study Endpoints

Primary Endpoints

best overall response (ORR)
2 years

As soon as evaluations for each tumor assessment are completed, the Investigator should assess the patient's overall response (target plus non- target lesions) based on criteria and overall response algorithms as defined in RECIST version 1.1. Scans must be assessable for all evaluations.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1: Lung cancers, HER2 mutantEXPERIMENTAL -
Cohort 2: Lung cancers, HER2 amplifiedEXPERIMENTAL -
Cohort 3: Colorectal cancersEXPERIMENTAL -
Cohort 4: Endometrial cancersEXPERIMENTAL -
Cohort 5: Salivary gland cancersEXPERIMENTAL -
Cohort 6: Other solid cancersEXPERIMENTAL -

Interventions

NameTypeDescription
ado-trastuzumab emtansineDRUGAdo-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Adults who are ≥18 years old. * Pathologically confirmed advanced solid tumor cancers * For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772\_A775dup), insGSP (G778\_P780dup), insTGT (G776delinsVC), single base...

Countries:United States
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