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 consent.
- 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 infusion. 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 hormone releasing system, bilateral 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.