Actively Recruiting
ASTEROID: A Trial of ASTX660 in Combination With Pembrolizumab
Led by Institute of Cancer Research, United Kingdom · Updated on 2026-02-10
61
Participants Needed
3
Research Sites
210 weeks
Total Duration
On this page
Sponsors
I
Institute of Cancer Research, United Kingdom
Lead Sponsor
A
Astex Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ASTEROID: A Trial of ASTX660 in Combination With Pembrolizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed advanced malignant solid tumours refractory to conventional treatment or no conventional therapy available or declined
- Patients with advanced solid tumours refractory to immune checkpoint inhibitors including melanoma, renal cell cancer, non-small cell lung cancer, head and neck squamous cell cancer, cervical cancer, triple negative breast cancer, glioblastoma, and ER positive HER2 negative breast cancer progressed on CDK4/6 inhibitor therapy
- Measurable or evaluable disease as assessed by imRECIST, whole body MRI, or RANO depending on cohort
- No more than two prior systemic lines of chemotherapy in metastatic setting for ER positive HER2 negative cohort
- Willing and able to have fresh paired tissue biopsies for biomarker analysis (Part A)
- Life expectancy of at least 12 weeks
- WHO performance status of 0 or 1
- Hematological and biochemical indices within specified ranges performed within one week prior to first dose
- Age 18 years or older
- Signed informed consent and capable of cooperating with treatment and follow-up
- Female patients with reproductive potential must have a negative pregnancy test within 72 hours of first dose
You will not qualify if you...
- Radiotherapy, endocrine therapy, immunotherapy including Pembrolizumab, or chemotherapy within 4 weeks prior to study treatment (6 weeks for nitrosoureas, Mitomycin-C) except permitted hormonal therapies and bone metastases treatments
- Current malignancies other than adequately treated in situ carcinoma of cervix and basal or squamous cell carcinoma of skin
- Ongoing Grade 2 or greater toxicities from prior treatments except alopecia and anticoagulation
- Pregnancy, lactation, or inability/unwillingness to use effective contraception
- Male patients with partners of childbearing potential not using effective contraception
- Untreated or active CNS metastases (for most cohorts), with exceptions for treated stable CNS metastases
- Major surgery within 4 weeks prior to first dose
- History of malabsorption or conditions interfering with enteral absorption
- High medical risk from non-malignant systemic disease or uncontrolled infection
- History or current pneumonitis/interstitial lung disease requiring steroids
- Positive for hepatitis B, hepatitis C, or HIV
- Active autoimmune disease requiring systemic treatment in past 3 months
- Immunodeficiency or recent systemic steroid/immunosuppressive therapy
- Live vaccine within 30 days before study therapy
- Certain cardiac abnormalities or recent serious cardiac events
- Prior bone marrow transplant or extensive radiotherapy to bone marrow within 8 weeks
- Participation in another interventional clinical trial
- Prior exposure to IAP antagonist (Smac mimetic)
- History of severe hypersensitivity to study drugs
- Known psychiatric or substance abuse disorders interfering with study participation
- History of allogenic tissue or solid organ transplant
- Symptoms or documented infection with COVID-19
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Cambridge University Hospitals NHS Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
2
The Royal Marden NHS Foundation Trust - Drug Development Unit
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
3
The Royal Marsden NHS Foundation Trust - Breast Unit
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
A
Anna Zachariou, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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