Clinical Trial Summary
Phase 1 & II, Interventional, multi-center, randomised, single-arm, multiple ascending dose study to evaluate the safety, pharmacokinetics & pharmacodynamics in patients diagnosed with AML
The purpose of this study is to determine the safety, tolerability, dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of CXD in patients with relapsed/refractory acute myeloid leukemia (AML).
Key Inclusion Criteria:
- Age ≥ 18 years at the time of screening.
- Subjects must have a documented diagnosis of acute myeloid leukemia (AML) (WHO 2016)
- Subjects non-eligible for intensive chemotherapy as first-line, second-line, or third-line treatment.
- Written informed consent and any locally required authorization
- Liver Function Tests: AST and ALT ≤ 3 × ULN, and serum TBL ≤ 1.5 × ULN, unless consistent with Gilbert’s syndrome for which TBL ≤ 2.5 × ULN is allowed.
- CrCL ≥ 40 mL/min 6. Female patients of childbearing potential who are sexually active with a non sterilized male partner must use at least one highly effective method of contraception from 7 days post-screening, and must agree to continue using such precautions for 90 days after the last dose of investigational product.
- Non Sterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 7 days post-screening and for 90 days after receipt of the last dose of investigational product
Key Exclusion Criteria:
- Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections at the time of screening.
- Patients at risk of non-disease related major bleeding (eg, recent GI hemorrhage or neurosurgery, within the previous 21 days).
- Current severe active systemic disease including active concurrent malignancy
- Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosoureas or mitomycin C) prior to the first scheduled dose of CXD.
- Received an investigational drug within 14 days of the first scheduled dose of CXD or not recovered from associated toxicities.
- Received any major surgery (as defined by the Investigator), radiotherapy, or immunotherapy (including immune checkpoint inhibitors and adoptive cellular therapy such as autologous or donor NK cell or T lymphocyte infusions (e.g. CAR -T cells)) within 28 days of the first scheduled dose of CXD.
- Patients who have previously received an autologous SCT, are excluded if less than 120 days have elapsed from the time of transplant or the patient has not recovered from transplant-associated toxicities prior to the first scheduled dose of CXD.
- History of liver cirrhosis, liver fibrosis or prior liver irradiation regardless of the time interval (not including total body irradiation administered during allogeneic SCT).
- Failure to recover from all prior treatment-related non-hematological toxicities to ≤ Grade 1 prior to the first scheduled dose of CXD (except for alopecia and neuropathy).
- Central nervous system (CNS) disease that is untreated, symptomatic, or requires therapy to control symptoms.
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