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Trial from ANZCTR

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.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 24/1/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616000787482

Date registered

16 June 2016

Health condition

Prostate cancer, Pancreatic cancer, Bladder cancer

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales

Recruitment status

Recruiting

Anticipated date of first participant enrolment

n/a

Ethics application status

Approved

Brief summary

The primary purpose of this trial is to examine the safety and tolerability of a newly developed antibody, MIL-38/Gallium67 (MILGa) for imaging metastases in adults with prostate, bladder or pancreatic cancer.
Who is it for?
You may be eligible to participate in this trial if you are aged 18 years or older, have been diagnosed with prostate, pancreatic or urothelial (bladder, ureter, urethra, renal pelvis) metastatic cancer, with between 2 and 15 metastases, with the cancer determined to be stable or progressing slowly.
Study details:
Patients 4-12 will be given a single dose of unlabelled chMIL38-DOTA one hour prior to MILGa drug infusion. All participants in this study will be given a single dose of MILGa, followed by various scans and blood tests for the following 4 weeks. Scans will include a range of CT scans, and patients will also be monitored for adverse events. It is hoped that the findings from this trial will provide information on the safety and tolerability of MILGa administration, and on the efficacy of the antibody for imaging metastases.
Cohort 2 (Patients 4, 5 and 6)
Patients in this cohort will be infused with 3.5 mg of unlabelled chMIL-38-DOTA prior to receiving 1 mg chMIL-38-DOTA labelled with 250 MBq 67Ga. Each patient in this cohort will be dosed 2 weeks apart.
Cohort 3 (Patients 7, 8 and 9)
Patients in this cohort will be infused with an incrementally higher dose within the range of 3.5 mg and 24 mg of unlabelled chMIL-38-DOTA prior to receiving 1 mg chMIL-38-DOTA labelled with 250 MBq 67Ga and. Each patient in this cohort will be dosed 2 weeks apart.

Cohort 4 (Patients 10, 11 and 12)
Patients in this cohort will be infused with an incrementally higher dose within the range of 3.5 mg and 24 mg of unlabelled chMIL-38-DOTA prior to receiving 1 mg chMIL-38-DOTA labelled with 250 MBq 67Ga. Each patient in this cohort will be dosed 2 weeks apart.

At end of each cohort:
Safety assessment by DSMC and preliminary assessment of chMIL-38-DOTA-67Ga scan utility will be determined. Furthermore, the effect of the dose of un-labelled chMIL-38-DOTA used per cohort on tumour targeting will be reviewed at the end of each cohort to determine the cold antibody dose for the subsequent cohort.

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key 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.

Contact details and further information

Primary Sponsor

Type: Commercial sector/Industry
Name: Minomic International
Address: Ground Floor, Suite 2, 75 Talavera Road, Macquarie Park, NSW 2113
Country: Australia

Contact person for information and recruitment

Prof Brad Walsh
Minomic International
Suite 2, Ground Floor, 75 Talavera Road, Macquarie Park, NSW 2113
Australia
+61 2 9850 4001
brad.walsh@minomic.com