ACTRN12616000787482CompletedPhase 1
MILGa-01: A first in human study to evaluate the safety and tolerability of monoclonal antibody conjugate MILGa (MIL-38/Gallium67) in patients with advanced prostate, bladder and pancreatic cancer.
Minomic International0 sites12 target enrollmentStarted: June 16, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Diagnosis
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •*Written informed consent provided.
- •*18 years old or older.
- •*Histologically or cytologically confirmed diagnosis of
- •a. Prostate cancer
- •b.Urothelial cancer (bladder, ureter, urethra, renal pelvis)
- •c.Pancreatic cancer
- •*Metastatic disease as assessed by CT, bone, or MRI within 14 days of MILGa scan.
- •a. At least two metastases and up to 15 metastases
- •b.Stable or slowly progressing disease as determined by the Investigator
- •c.For prostate cancer the minimal standard scans is CT Chest/Abdomen/Pelvis (CAP) and whole body bone scan.
- •d.For urothelial and pancreas cancer the minimal standard scans is CT CAP.
- •* No change of anti-cancer therapy within 4 weeks of study entry and none planned for at least 2 weeks after study entry.
- •*Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. Subjects with performance status of 2 may be enrolled in at the discretion of the Investigator.
- •*Male subjects must agree to use contraception methods. This criterion must be followed from the time of the dose of study medication until 4 weeks after.
- •*A female subject is eligible to participate if she is of:
- •a.Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and oestradiol < 40 pg/mL (<140 pmol/L) is confirmatory].
- •b.Child-bearing potential and agrees to use contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until four weeks after the last dose of study medication.
- •*Adequate organ system function
Exclusion Criteria
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1.Patients with extensive bone marrow involvement as defined by abnormal haematological values or prostate cancer patients with super scan” on standard imaging (nuclear bone scan)
- •2.Change in anti-cancer therapy planned for 4 weeks before or two weeks after MILGa scan.
- •3.Currently receiving cytotoxic chemotherapy that is expected to cause grade 3 neutropenia or grade 3 thrombocytopenia.
- •4.Patients with rapidly progressing metastatic disease as determined by the Principal Investigator
- •5.Any major surgery, radiotherapy or immunotherapy in the four weeks preceding MILGa dosing
- •6.Concurrent condition precluding the patient from following study protocol.
- •7.QTc interval of greater than 450 msec
- •8.Unwillingness or inability to follow study procedures.
- •9.Known immediate or delayed hypersensitivity reactions to study drug.
Investigators
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