MOLECULARLY TARGETED: ROS1 fusion: myTACTIC Arm A

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm A: Entrectinib in patients with ROS1 fusion-positive tumors

Title
Genentech ML42439 (myTACTIC) ROS1
Study Title

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm A: Entrectinib in patients with ROS1 fusion-positive tumors

Site Link
Malignancy
Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Ideally 1st line, but can be later line as well
Investigational Agent
Entrectinib
Drug Class
TKI against NTRK, ROS, and ALK
PI
Axel Grothey, MD
Sponsor
Genentech, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • ROS1 gene fusion positivity
  • No non-small lung cancer (NSCLC)
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
Objective
  • Primary-
    • ORR
  • Secondary
    • PFS
    • DoR
    • OS
    • PFS at various time points
    • DCR
    • Safety
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
ROS1 fusion. Any cancer type except not NSCLC
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X