Phase II open label study designed to evaluate the efficacy and safety of P-Sam in patients with aggressive, solid, NOTCH mutant or p63 low (B7-H4 high) R/M ACC-I patients.
Patients ≥18 years with histology-proven advanced, or R/M ACC.
Evidence of locally advanced disease not amenable to curative intent surgery or radiotherapy, or recurrent/metastatic disease
Presence of an activating NOTCH mutation per in-house or any CLIA-certified or commercially available next-generation sequencing assay
Solid histology and clinical course characterized by < 3 years from diagnosis to initial recurrence or progression or de novo metastatic disease with extra-pulmonary metastasis
Unresolved toxicities of Grade ≥ 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE version 5.0) from prior therapy (excluding vitiligo, alopecia, endocrine disorders that are controlled with replacement hormone therapy, and lymphopenia unless it is accompanied by clinical signs of infection or the indication for prophylaxis with antibiotic/antiviral/antifungal therapy). Participants with chemotherapy-induced Grade 2 neuropathy may be eligible at discretion of the Investigator.
Negative for HBsAg and positive for total hepatitis B core antibody (anti-HBc) or Positive for HBsAg, but for > 6 months have had normal transaminases and HBV DNA levels between 0-2000 IU/mL (inactive carrier state) and willing to start and maintain antiviral treatment for at least the duration of the study.
HBV DNA levels > 2000 IU/mL but on prophylactic antiviral treatment for the past 3 months and will maintain the antiviral treatment during the study.
Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction test result is negative for HCV RNA.
M.D. Anderson Cancer Center
Lead sponsor
AstraZeneca
Collaborator