A long term follow up study, to evaluate the long term safety and efficacy, of single agent ATX-101 given by intravenous infusion once every week in patients with advanced solid tumours

Therapim Pty Ltd0 个研究点目标入组 36 人开始时间: 2018年7月5日最近更新: 2021年3月8日

适应症

试验速览

暂无简介。

•1.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.
•2.Signed written informed consent.
•3.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
•4.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.

•1.Evidence of disease progression according to RECIST V1.1 during AM ATX101-01.
•2.Concurrent anticancer treatment (e.g., cytoreductive therapy, radiotherapy except for palliative bone-directed radiotherapy, immune therapy, or cytokine therapy except for erythropoietin) within 21 days or 5x (five times) their half-lives (whichever is shorter) before the first dose of trial treatment.
•3.Use of hormonal agents within 7 days before start of trial treatment, except for subjects with castration-resistant prostate cancer (CRPC), who may remain on treatment with luteinizing hormone–releasing hormone agonists or antagonists.
•a. Note: Subjects receiving bisphosphonate or denosumab are eligible provided that treatment was initiated more or equal to 14 days before first dose of treatment.
•4.Anticipated requirement for surgery or initiation of anti-cancer therapy during the study period.
•5.Breastfeeding or pregnant as confirmed by a positive serum beta human chorionic gonadotropin (ß-HCG) pregnancy test at screening or at subsequent clinic visits.
•6.Unwilling or unable to follow protocol requirements.
•7.Inadequate venous access to allow collection of blood samples.

发起方