MOLECULARLY TARGETED: HER2 mut/expr: Metastatic; >/= 2nd line; My Pathway-HER2

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

Title
Genentech ML28897 HER2
Study Title

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

Site Link
Malignancy
biliary cancer, cholangiocarcinoma, salivary gland, bladder, transitional cell carcinoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
> 2nd line
Investigational Agent
trastuzumab/pertuzumab
Drug Class
anti-HER2 monoclonal antibodies
PI
Ari VanderWalde, MD
Sponsor
Genentech, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details

 

  • One of the following malignancies
    • Biliary cancer
    • Salivary gland cancer
    • Bladder cancer
  • HER2 overexpression or amplification
  • ECOG PS 0-2
  • No prior treatment with any HER-2 directed therapy
  • No active or untreated CNS metastastasis
  • LVEF must be > or = 50%
Objective

Primary- ORR; Secondary- DCR, PFS, 1-year OS

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
HER2 overexpression or amplification
Dosing Frequency

Trastuzumab 6mg/kg IV q3 weeks; Pertuzumab 420mg IV q3 weeks

Control Agents
None
Study Protocol
Randomized
No
X