A study to evaluate the safety, tolerability and pharmacokinetics of ACT001 in patients with advanced solid tumors (PART B).
- Conditions
- Glioblastoma MultiformeCancer - Brain
- Registration Number
- ACTRN12621001172897
- Lead Sponsor
- Accendatech AU Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 21
1. Histologically or cytologically confirmed advanced or metastatic glioblastoma with no standard treatment options.
2. Patients with recurrent glioblastoma who satisfy all of the following may be
enrolled:
- Progressive tumor despite prior treatment with radiation therapy and
temozolomide
- Measurable disease by Response Assessment in Neuro-Oncology (RANO)
criteria using gadolinium-enhanced MRI scanning
- Either on no glucocorticoids or on a stable dose for 7 days prior to the first
dose of study therapy that is equivalent to = 12.5 mg of prednisone daily
- No evidence of intracranial hemorrhage (except for stable grade 1
hemorrhage), not receiving therapeutic anticoagulation or anti-platelet
therapy, and have a normal INR and APTT
- No radiation in the past 3 months
3. Male or female and at least 18 years of age.
4. Adequate organ function (ANC greater than or equal to 1.5 × 109 /L, lymphocytes greater than or equal to 0.5 × 109 /L,
platelets greater than or equal to 75 × 109 /L, Hb greater than or equal to 10 g/dl; total bilirubin less than or equal to 1.5 × institutional upper
limit of normal (ULN); ALT and AST less than or equal to 2.5 × ULN (less than or equal to 5.0 × ULN if liver metastasis); plasma creatinine less than or equal to 1.5 × ULN; QTc < 450 ms (male), < 470 ms (female).
5. A life expectancy of at least 12 weeks.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
7. Female subjects are eligible if they are of:
a) Non-childbearing potential, defined as
- Previous hysterectomy or bilateral oophorectomy
- Previous bilateral tubal ligation
- Post-menopausal (total cessation of menses for greater than or equal to 1 year)
b) Childbearing potential with a negative serum pregnancy test at screening
(within 7 days of the first investigational product administration), and uses
adequate contraception before study entry and throughout the study until 28 days
after the last investigational product administration. Adequate contraception,
when used consistently and in accordance with both the product label and the
instructions of the physician, are defined as follows:
- Vasectomized partner who is sterile prior to the female patient’s enrolment
and is her sole sexual partner
- An intrauterine device with a documented failure rate of less than 1% per
year
- Double barrier contraception defined as condom with a female diaphragm
8. Male patients, if sexually active, must agree to use a highly-effective method of
contraception (< 1% failure rate per year) with their female partners
9. Provided written informed consent prior to enrollment.
-The patient has an uncontrolled infection.
-The patient has serious diseases or stroke within 6 months prior to enrolment.
-The patient has a gastrointestinal absorption disorder or cannot take oral drugs.
-Uncontrolled brain metastases or spinal cord compression. Patients who were treated with surgical resection or radiation therapy at least 4 weeks earlier are eligible if they are neurologically stable, not taking glucocorticoids and have had an MRI scan performed within the previous 4 weeks showing no tumour progression. (GBM patients taking a steroid dose equivalent to 12.5mg of prednisone are eligible)
-Pre-existing allergy to ACT001 or pembrolizumab or related compounds.
-Treatment with other cancer therapies such as chemotherapy, biological or targeted therapy, immunotherapy or radiation therapy either currently or within 4 weeks of ACT001 dosing (6 weeks for BCNU, CCNU or mitomycin-C). Pembrolizumab is exempt from this exclusion in Part B
-Unresolved toxicity from prior anti-tumour therapy.
-Patients with active autoimmune diseases or history of autoimmune diseases except for patients with vitiligo or alopecia, or those with hypothyroidism following autoimmune thyroiditis on a stable replacement dose of thyroid hormone are not excluded.
-Patients who have received chronic glucocorticoid treatment at levels above the equivalent of prednisone at > 12.5 mg/day or dexamethasone at > 2 mg/day, or other immunosuppressive medication within 14 days prior to the first dose of the study drug.
-Major surgery within 30 days of commencing first study therapy.
-Patients who have received organ transplantation
-Pregnant or breast-feeding females.
-A history of infection with HIV or hepatitis B or C viruses
-The subject has participated in other drug clinical trials within 4 weeks prior to informed consent.
-The subject is, in the opinion of the investigator, unsuitable for any reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method