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MOLECULARY TARGETED: NTRK1/2/3 FUSION (TAPISTRY ARM B)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort B: Entrectinib in patients with NTRK1/2/3 fusion-positive tumors

Title
ROCHE BO41932: TAPISTRY ARM B
Study Title

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort B: Entrectinib in patients with NTRK1/2/3 fusion-positive tumors

Site Link
Malignancy
any solid tumors
Stage
Disease Setting
metastatic or advanced
Line Of Therapy
any
Investigational Agent
Entrectinib
Drug Class
selective tyrosine kinase inhibitor
PI
Daniel Vaena, MD
Sponsor
Hoffmann-La Roche
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details

Inclusion Criteria:

  • Any Solid Malignancy with NTRK1/2/3 Fusion Positivity
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
Objective

Overall Response Rate

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X