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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Malignant neoplasm of breastMalignant neoplasms of eye, brain and other parts of central nervous systemMalignant neoplasms of female genital organs
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This is a multi-centre Phase I dose finding and proof-of-concept study of the combination of ASTX660 together with Pembrolizumab with expansion cohorts testing preliminary efficacy in immune-refractory cancers, triple negative breast cancer (TNBC), cervical cancer, and glioblastoma.
In contrast to the existing studies combining first-generation cIAP1/2 selective Smac mimetics with immune check point inhibitors, the ASTEROID Phase I clinical trial will be the first trial utilising triple cIAP1/2 and XIAP blockade by ASTX660 as a strategy to maximise immunogenic cell death and the generation of an efficient adaptive immune response. ASTX660 is not simply being used to repeat the data already being acquired with other first generation Smac mimetics. In contrast, we will investigate more in depth the mechanisms by which ASTX660 elicits its therapeutic effects both on tumour and on the host immune system. This will be critical to determine the best strategy to pursue in future later stage tumour specific trials of IAP antagonists in combination with immunotherapy, and to ensure appropriate molecular stratification biomarkers for the greatest benefit to patients.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
.Radiotherapy, endocrine therapy, immunotherapy including Pembrolizumab or chemotherapy during the previous four weeks (6 weeks for nitrosoureas, Mitomycin-C and 4 weeks for investigational medicinal products) before treatment, except for hormonal therapy with LHRH analogues for medical castration in patients with castrate resistant prostate cancer or ovarian suppression in pre- or peri-menopausal women with endocrine driven breast cancer, which are permitted, and bisphosphonates or RANK ligand antagonists that are permitted for the management of bone metastases. . Current malignancies of other types, with the exception of adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years or more and are deemed at negligible risk for recurrence, are eligible for the trial. .Ongoing Grade 2 or greater toxicities of previous treatments. Exceptions to this are alopecia. .Ability to become pregnant/already pregnant/lactating.However, those female patients who have a negative serum pregnancy test before enrolment and agree to use 2 highly effective forms of contraception from time of consent, during the trial and for 6 months afterwards are considered eligible. Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception .Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception and not to donate sperm during the trial and for 6 months afterwards). . Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] and not to donate sperm during the trial and for six months afterwards). Men with pregnant or lactating partners should be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure to the foetus or neonate .Known untreated or active CNS metastases. Patients with a history of treated CNS metastases are eligible, provided they meet the criteria in the protocol. .Major surgery within 4 weeks of the first dose of study treatment. .History of malabsorption syndrome or other condition that would interfere with enteral absorption. .At high medical risk because of non-malignant systemic disease including active uncontrolled infection. .Known to be serologically positive for hepatitis B, hepatitis C or HIV or known history of liver disease .Has an active autoimmune disease that has required systemic treatment in past 3 months. Replacement therapy is not considered a form of systemic treatment. Patients with Sjogren’s syndrome will not be excluded from the study. In addition patients that experienced a Grade 2 or higher immune-related AE’s on treatment with immunotherapy or a history of IBD will will be excluded from the study. Patients with inactive autoimmune disease which has previously required systemic therapy, may be considered on a case-by-case basis after discussion with the sponsor. .Has a diagnosis of immunodeficiency/receiving systemic steroid therapy/any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the CI. Stable use of inhaled corticosteroids is allowed. .Has received a live vaccine within 30 days of planned start of study therapy. The killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines are live attenuated vaccines and are not allowed. .Any of the cardiac criteria listed in the protocol .Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of bone marrow within 8 weeks. . History of non-infectious pneumonitis that required steroids, or current pneumonitis. .Participates or plans to participate in another interventional clinical trial, whilst taking part in this Phase I study. Participation in an observational trial would be acceptable. .Prior exposure to an IAP antagonist (Smac mimetic) will be excluded. Patients with prior exposure to immunotherapy will be permitted as they did not experience any immune-adverse event toxicity while on their prior immunotherapy. . Symptoms of COVID-19 and/or documented CPVID-19 infection.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Institute of Cancer Research: Royal Cancer Hospital and funded by ASTEX THERAPEUTICS LIMITED; CANCER RESEARCH UK; .
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for Trial ID: CPMS 50829
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