7 results
The primary objective of this study is to assess the potential clinical efficacy of HGT-1410administered via a surgically implanted IDDD in patients with MPS IIIA. Efficacy will bemeasured as a meaningful amelioration in the progression of cognitive…
To evaluate safety and feasibility of neoadjuvant chemotherapy-free regimen with trastuzumab, pertuzumab and tucatinib in stage II-III HER2-positive breast cancer.
Dose escalation phase:Primary• Determine the RP2D and if reached, the MTD of GEN3014• Evaluate the safety and tolerability of GEN3014 Secondary:• Characterize the PK properties of GEN3014• Characterize the pharmacodynamic properties of GEN3014•…
Primary* Compare progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria inSolid Tumors (RECIST) v1.1 between treatment armsKey Secondary* Compare overall survival (OS) between treatment arms* Compare PFS by…
Primary ObjectiveTo evaluate the antitumor activity of tucatinib given in combination with trastuzumab in subjects with previously treated, locally-advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) overexpressing/…
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and pertuzumab as maintenance therapy in subjects with advanced HER2+ breast cancer who have had prior treatment with a taxane, trastuzumab, and pertuzumab.
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and mFOLFOX6 in comparison to mFOLFOX6 given with or without either bevacizumab or cetuximab as first-line (1L) treatment in adults with HER2 positive (HER2+)…