Brief Summary
This is a Phase I, open-label, single arm, long term follow up study to assess safety of ATX-101 in subjects with advancedat a late stage, far along solid tumours over a maximum period of 12 months.
Intervention/Treatment
- Drug: ATX-101
Inclusion Criteria
- Subjects with advanced solid tumours who have completed at least six infusions of ATX-101 in study AM ATX101-01 with no progressive disease based on RECIST V1.1 at the AM ATX101-01 EOS visit.
- Signed written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
- Women of child-bearing potential (WOCBP) must use highly effective contraceptive measures (failure rate of < 1% per year when used consistently and correctly) and intend to continue use of contraception for at least 1 month following the last infusionto slowly introduce/give fluid into a vein. Highly effective contraceptive measures could include: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body releasing system, bilateralaffecting both sides tubal occlusion, vasectomized partner, and sexual abstinence.
- Males who are not surgically sterile must use a condom through to study completion and for 30 days after the last treatment administration, unless they have a female partner who is surgically sterile or post-menopausal. They must refrain from fathering a child during this time.