Squamous Cell Carcinoma

24004- A phase 3 open-label, randomized, controlled study to evaluate the efficacy and safety of petosemtamab compared with investigator’s choice monotherapy treatment in previously treated patients with incurable, metastatic/recurrent head and neck squamous cell carcinoma (MCLA-158-CL02) – 24004
STAR TRIAL = 2 WEEKS TO OPEN
Eligible primary tumors: oropharynx, oral cavity, hypopharynx, larynx, Investigator choice monotherapy: methotrexate, cetuximab, docetaxel

  • Phase – 3
  • Stage(s) – Incurable, metastatic/current
  • Line of Therapy – 2nd
  • Investigational Drug – Petosemtamab
  • Drug Class – anti-EGFR and anti-LGR5
  • Mechanism of Action – Petosemtamab: Low fucose, common light chain human full-length IgG1 bispecific antibody targeting EGFR and LGR5

Esophageal

24169- A Phase 2, open-label, multicenter study to evaluate efficacy and safety of zanidatamab for the treatment of participants with previously treated HER2-expressing solid tumors (DiscovHER PAN-206) (JZP598-206)

  • Phase – II
  • Stage(s) – locally advanced, unresectable, or metastatic solid tumors
  • Line of Therapy – Participants in all cohorts must have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit
  • Investigational Drug – zanidatamab
  • Mechanism of Action – Zanidatamab is a bispecific, HER2-directed antibody
  • Biomarker(s) – HER2 IHC 3+ overexpression