RE: Best in class FAP inhibitor20 Mar 2022 08:51
Patients with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen [antiHBc] antibody test) are
eligible.
2. Patients positive for HCV antibody are eligible only if PCR is negative for HCV
RNA
11. Severe infection(requiring IV treatment)within 21 days prior to Cycle 1, Day 1
including, but not limited to, hospitalisation for complications of infection,
bacteraemia, or severe pneumonia
12. Any other clinically significant active disease, metabolic dysfunction, physical
examination finding, clinical laboratory finding, or reasonable suspicion of a disease
or condition that would contraindicate the use of an investigational drugin the
opinion of the investigator.
13. Major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or
anticipates the need for major surgery during study treatment
14. Has dementia or altered mental status that in the opinion of the investigator would
preclude providing informed consent
15. Pregnant or breastfeeding woman
16. Known hypersensitivity to any of the components of AVA6000 or any excipient related to
the product
17. Received prior investigational therapy (defined as a treatment for which there is no
Regulatory Authority-approved indication) within 21 or 42 days of Cycle 1 Day 1, for
small molecule and biologic investigational therapies, respectively.
18. Received any approved anticancer therapy, including chemotherapy or hormonal therapy,
within 28 days prior to Cycle 1, Day 1, with the following exceptions:
1. Hormone-replacement therapy or oral contraceptives
2. Tyrosine kinase inhibitors (TKIs) that have been discontinued more than 7 days
prior to Cycle1, Day 1
19. Is planned for on study treatment or has received within 21 days prior to Cycle 1, Day
1: St John's Wort, any strong inhibitor or inducer of CYP3A4, CYP2D6, narrow
therapeutic index CYP1A2, CYP2B6, or P-glycoprotein (PGP) ¸ or any moderate OATP1B3
inhibitor (will include statins)
20. Received systemic immunosuppressive medication (for any indication) at doses of >10mg
prednisolone (or equivalent) within 28 days prior to Cycle 1, Day 1.
21. Received radiotherapy within 28 days prior to Cycle 1, Day 1, except for limited field
palliative radiotherapy. Patients who have received prior or concomitant radiotherapy
to the mediastinal area are also excluded.
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