ACTRN12618001112257
Recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Solid Tumors
- Sponsor
- Therapim Pty Ltd
- Enrollment
- 36
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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